EGYPT
PHARMACEUTICAL COUNTRY PROFILE
Egypt Pharmaceutical Country Profile Published by the Ministry of Health Egypt in collaboration with the World Health
Organization
July 2011
Any part of this document may be freely reviewed, quoted, reproduced, or translated in full or in part, provided that the source is acknowledged. It may not be sold, or used in
conjunction with commercial purposes or for profit.
Users of this Profile are encouraged to send and comments or queries to the following address:
The Chief Pharmacist Dr Mahmoud Diaa, Pharm D
Email: [email protected]
This document was produced with the support of the World Health Organization (WHO) Egypt Country Office, and all reasonable precautions have been taken to verify the information contained herein. The published material does not imply the expression of any opinion
whatsoever on the part of the World Health Organization, and is being distributed without any warranty of any kind – either expressed or implied. The responsibility for interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for
damages arising from its use.
Foreword
The 2011 Pharmaceutical Country Profile for Egypt has been produced by the
Ministry of Health, in collaboration with the World Health Organization.
This document contains information on existing socio-economic and health-
related conditions, resources; as well as on regulatory structures, processes and
outcomes relating to the pharmaceutical sector in Egypt. The compiled data
comes from international sources (e.g. the World Health Statistics1,2), surveys
conducted in the previous years and country level information collected in 2011.
The sources of data for each piece of information are presented in the tables that
can be found at the end of this document.
On the behalf of the Ministry of Egypt, I wish to express my appreciation to
Dr.Mahmoud Diaa, PharmD from the MOH Central Administration for
Pharmaceutical Affairs for his contribution to the process of data collection and
the development of this profile.
It is my hope that partners, researchers, policy-makers and all those who are
interested in the Egypt pharmaceutical sector will find this profile a useful tool to
aid their activities.
Aiman Saad El-Khatib Assistant Minister of Health and Population for Pharmaceutical Affairs
Date: 27-11-2011
Table of content
Foreword .............................................................................................................. iii
Table of content .................................................................................................... v
Introduction ........................................................................................................... 1
Section 1 - Health and Demographic Data ........................................................ 3
Section 2 - Health Services ................................................................................ 5
Section 3 - Policy Issues .................................................................................... 9
Section 4 – Medicines Trade and Production ................................................. 11
Section 5 – Medicines Regulation ................................................................... 13
Section 6 - Medicines Financing ...................................................................... 22
Section 7 - Pharmaceutical procurement and distribution in the public sector ................................................................................................................. 27
Section 8 - Selection and rational use of medicines ...................................... 29
Section 9 - Household data/access ................... Error! Bookmark not defined.
Introduction
This Pharmaceutical Country Profile provides data on existing socio-economic
and health-related conditions, resources, regulatory structures, processes and
outcomes relating to the pharmaceutical sector of Egypt. The aim of this
document is to compile all relevant, existing information on the pharmaceutical
sector and make it available to the public in a user-friendly format. In 2010, the
country profiles project was piloted in 13 countries
(http://www.who.int/medicines/areas/coordination/coordination_assessment/en/in
dex.html). During 2011, the World Health Organization has supported all WHO
Member States to develop similar comprehensive pharmaceutical country
profiles.
The information is categorized in 9 sections, namely: (1) Health and
Demographic data, (2) Health Services, (3) Policy Issues, (4) Medicines Trade
and Production (5) Medicines Regulation, (6) Medicines Financing, (7)
Pharmaceutical procurement and distribution, (8) Selection and rational use, and
(9) Household data/access. The indicators have been divided into two categories,
namely "core" (most important) and "supplementary" (useful if available). This
narrative profile is based on data derived from both the core and supplementary
indicators. The tables in the annexes also present all data collected for each of
the indicators in the original survey form. For each piece of information, the year
and source of the data are indicated; these have been used to build the
references in the profile and are also indicated in the tables. If key national
documents are available on-line, links have been provided to the source
documents so that users can easily access these documents.
The selection of indicators for the profiles has involved all technical units working
in the Essential Medicines Department of the World Health Organization (WHO),
as well as experts from WHO Regional and Country Offices, Harvard Medical
School, Oswaldo Cruz Foundation (known as Fiocruz), University of Utrecht, the
Austrian Federal Institute for Health Care and representatives from 13 pilot
countries.
Data collection in all 193 member states has been conducted using a user-
friendly electronic questionnaire that included a comprehensive instruction
manual and glossary. Countries were requested not to conduct any additional
surveys, but only to enter the results from previous surveys and to provide
centrally available information. To facilitate the work of national counterparts, the
questionnaires were pre-filled at WHO HQ using all publicly-available data and
before being sent out to each country by the WHO Regional Office. A coordinator
was nominated for each of the member states. The coordinator for Egypt was
Mahmoud Elmahdawy, Pharm D.
The completed questionnaires were then used to generate individual country
profiles. In order to do this in a structured and efficient manner, a text template
was developed. Experts from member states took part in the development of the
profile and, once the final document was ready, an officer from the Ministry of
Health certified the quality of the information and gave formal permission to
publish the profile on the WHO web site.
This profile will be regularly updated by CAPA, Hospital Pharmacy Administration.
Comments, suggestions or corrections may be sent to:
Dr Mahmoud Diaa, pharm D 21 Abd El-Aziz Al Soud St, El Manial
Cairo
Egypt
PO: 11451
Section 1 - Health and Demographic Data This section gives an overview of the demographics and health status of Egypt. 1.1 Demographics and Socioeconomic Indicators The total population of Egypt in 2009 was 82,999,000 with an annual population
growth rate of 1.9%1. The annual GDP growth rate is 4.6 %3. The GDP per
capita was US$ 2,270 (at the current exchange ratei)3.
32% of the population is under 15 years of age, and 7% of the population is over
60 years of age. The urban population currently stands at 43% or the total
population. The fertility rate in Egypt is 2.8 births per woman.1 2 % of the
population is living with less than $1.25/day (international PPP). The income
share held by the lowest 20% of the population is 9% (as a % of national
income).3 The adult literacy rate for the population over 15 years is 66 %.1
1.2 Mortality and Causes of Death The life expectancy at birth is 69 and 73 years for men and women respectively.
The infant mortality rate (i.e. children under 1 year) is 18/1,000 live births. For
children under the age of 5, the mortality rate is 21/1,000 live births. The
maternal mortality rate is 82/100,000 live births1.
The top 10 diseases causing mortality in Egypt are (Ministry of Health Egypt,
2011, data from 2010)
Disease 1 Essential primary Hypertension
2 Intracerebral Hemorrhage
3 Fibrosis and cirrhosis of liver
4 Hepatic Failure
5 Atherosclerosis
6 Elevated Blood Glucose level
i The exchange rate for calculation for EGP is 1 USD = 5.49 EGP (2008 average exchange rate), 1 USD = which is consistent with the timing of the collection of related NHA data. The current exchange rate used is 1 USD = 5.97 EGP (28-06-2011)
7 Arterial Embolisim and thrombosis
8 Acute myocardial infarction
9 Cerebral infarction
10 other
The top 10 diseases causing morbidity in Egypt are (Ministry of Health Egypt,
2011, data from 2010)
Disease 1 Infectious Gastroenteritis
2 Spontaneous Labor
3 Caesarean section
4 Acute appendicitis
5 Iron deficiency anemia
6 Respiratory Distress Syndrome (RDS)
7 Broncho pneumonia
8 Acute tonsillitis
9 Forearm Fracture
10 Non specific renal colic
Section 2 - Health Services This section provides information regarding health expenditures and human
resources for health in Egypt. The contribution of the public and private sector to
overall health expenditure is shown and the specific information on
pharmaceutical expenditure is also presented. Data on human resources for
health and for the pharmaceutical sector is provided as well.
2.1 Health Expenditures In Egypt, the total annual expenditure on health (THE) in 2009 was 61,400 million
EGP (10,962 million US$)4. The total annual health expenditure was 5.8 % of the
GDP. The total annual expenditure on health per capita was 740 EGP
(US$ 132)5.
The general government health expenditure (GGHE) in 2009, as reflected in the
national health accounts (NHA) was 15,200 million EGP (US$ 2,713 million).
That is 24.76 % of the total expenditure on health, with a total annual per capita
public expenditure on health of 183.13 EGP (US$ 32.69). The government
annual expenditure on health represents 4.3 % of the total government budget.
Private health expenditure covers the remaining 95.7 % of the total health
expenditure. 4
Of the total population, 51 % is covered by a public health service, public health
insurance or social insurance, or other sickness funds. Data of the % of total
population covered by private health insurance is not available.
Total pharmaceutical expenditure (TPE) in Egypt in 2009 was 21,000 million
EGP (US$ 3,559 million), which is a per capita pharmaceutical expenditure of
253 EGP (US$ 42.89). The total pharmaceutical expenditure accounts for 1.89 %
of the GDP and makes up 34.20 % of the total health expenditure Figure 1.
Public expenditure on pharmaceuticals represents 23.31 % of the total
expenditure on pharmaceuticals (Figure 2), this converts into a per capita public
expenditure on pharmaceuticals of 31EGP (US$ 5.6)6.
FIGURE 1: Share of Total Pharmaceutical Expenditure as percentage of the Total Health Expenditure 2009. The THE in 2009 was 61,400 million EGP (10,962 million US$)
Source: NHA 2009
FIGURE 2: Share of Total Pharmaceutical Expenditure by sector 2008
NHA 2007-2008
Total private expenditure on pharmaceuticals is 8,445.71 million EGP
(US$ 1,431.45). 7 Private out-of-pocket expenditure as % of private health
34.2 %
65.8 %
TPE
other
23.31%
76.69%
Public sector
Private sector
expenditure is 95.14 %. Premiums for private prepaid health plans are 0.22 % of
total private health expenditure.7
2.2 Health Personnel and Infrastructure The health workforce is described in the table below and in Figure 3. There are
139,479 (16.8 /10,000) licensed pharmacists, of which 15,457 (1.86 /10,000)
work in the public sector. (The number of pharmacists may be slightly lower than
the actual number because a small number work in miscellaneous public jobs
and are included in any total database.)
There are 232,203 (27 /10,000) physicians and 280.561 (35.2 /10,000) nursing
and midwifery personnel in Egypt. The ratio of doctors to pharmacists is 1.6 and
the ratio of doctors to nurses and midwifery personnel is 0.8.
Table 1: Human resources for health in Egypt (2011)
Human Resource
Licensed pharmacists (all sectors) 139,479 (16.8 /10,000)8
Pharmacists in the public sector 15,457 (1.9 /10,000)11
Pharmaceutical technicians and assistants unknown
Physicians (all sectors) 223,203 (27 /10,000)9
Nursing and midwifery personnel (all sectors) 280,561 (35.2 /10,000)1
Figure 3: The density of the Health Workforce 2011 in Egypt (all sectors)
Source: Egyptian Pharmacists Syndicate; CAPA; Egyptian Medical Syndicate; WHS 2011
In Egypt, there is a strategic plan for pharmaceutical human resource
development in place (objectives of development that will be made into a plan)10.
The health workforce is described in the table below. There are 1,969 hospitals
and 15.49 hospital beds per 10,000 pop in Egypt. There are 5,034 primary
health care units and centres and 59,798 licensed pharmacies.
Table 2: Health centre and hospital statistics
Infrastructure
Hospitals 196911
Hospital beds 128,573 (15.49/10,000)11
Primary health care units and centres 503411
Licensed pharmacies (only community pharmacies
without hospital pharmacies)
59,79810
The annual starting salary for a newly registered pharmacist in the public sector
is 13,800 EGP. Accreditation requirements for pharmacy schools are in place.
The pharmacy Curriculum is regularly reviewed.
0 5 10 15 20 25 30 35 40
Pharmacists
Physicians
Nursing and midwifery personnel
/10,000 population
Section 3 - Policy Issues This section addresses the main characteristics of the pharmaceutical policy in
Egypt. The many components of a national pharmaceutical policy are taken from
the WHO publication “How to develop and implement national drug policy”
(http://apps.who.int/medicinedocs/en/d/Js2283e/). Information about the capacity
for manufacturing medicines and the legal provisions governing patents is also
provided.
3.1 Policy Framework In Egypt, a National Health Policy (NHP) exists.12 It was updated in 2005. An
associated National Health Policy implementation plan written in 2006 also
exists.12
An official National Medicines Policy document exists in Egypt13. It was updated
in 2005. A NMP implementation plan does not exist. Policies addressing
pharmaceuticals exist, as detailed in Table 214. Pharmaceutical policy
implementation is regularly monitored/assessed by the Egyptian Drug Authority
(EDA).15
Table 3: The NMP/group of policies cover:13 14
Aspect of policy Covered
Selection of essential medicines Yes
Medicines financing Yes
Medicines pricing Yes
Medicines Procurement Yes
Medicines Distribution Yes
Medicines Regulation Yes
Pharmacovigilance Yes
Rational use of medicines Yes
Human Resource Development Yes
Research No
Monitoring and evaluation Yes
Traditional Medicine No
A policy relating to clinical laboratories does not exist. An associated National
clinical laboratory policy implementation plan does not exist. Access to essential
medicines/technologies as part of the fulfillment of the right to health, is
recognized in the constitution or national legislation14. There are official written
guidelines on medicines donations13.
There is no national good governance policy in Egypt. (Comment: There is
limited non-governmental good governance in Egypt to our knowledge.)
A policy is in place to manage and sanction conflict of interest issues in
pharmaceutical affairs. There is an associated formal code of conduct for public
officials. A whistle-blowing mechanism that allows individuals to raise concerns
about wrongdoing occurring in the pharmaceutical sector of Egypt exists16. Each
Ministry in the government has an office for Citizen's Services, where any citizen
can report any wrongdoing occurred with him in that ministry. Then this complaint
is processed for further investigation.
Section 4 – Medicines Trade and Production 4.1 Intellectual Property Laws and Medicines Egypt is a member of the World Trade Organization17. Legal provisions granting
patents to manufacturers exist. These cover pharmaceuticals.
Intellectual Property Rights are managed and enforced by the Egyptian Patent
Office (ASRT) (URL: www.egypo.gov.eg)18.
National Legislation has been modified to implement the TRIPS Agreement and
contains TRIPS-specific flexibilities and safeguards19, presented in Table 4.
Egypt is not eligible for the transitional period to 2016.
Table 4: TRIPS flexibilities and safeguards are present in the national law
Flexibility and safeguards Included
Compulsory licensing provisions that can be applied for reasons of
public health
Yes
Bolar exceptionsii Yes
Parallel importing provisions Yes
ii Many countries use this provision of the TRIPS Agreement to advance science and technology. They allow researchers to use a patented invention for research, in order to understand the invention more fully. In addition, some countries allow manufacturers of generic drugs to use the patented invention to obtain marketing approval (for example from public health authorities) without the patent owner’s permission and before the patent protection expires. The generic producers can then market their versions as soon as the patent expires. This provision is sometimes called the “regulatory exception” or “Bolar” provision. Article 30 This has been upheld as conforming with the TRIPS Agreement in a WTO dispute ruling. In its report adopted on 7 April 2000, a WTO dispute settlement panel said Canadian law conforms with the TRIPS Agreement in allowing manufacturers to do this. (The case was titled “Canada - Patent Protection for Pharmaceutical Products”) [In: WTO OMC Fact sheet: TRIPS and pharmaceutical patents, can be found on line at: http://www.wto.org/english/tratop_e/trips_e/tripsfactsheet_pharma_2006_e.pdf]
There are no legal provisions for data exclusivity for pharmaceuticals, patent
term extension or linkage between patent status and marketing authorization.
The country is engaged in capacity-strengthening initiatives to manage and apply
Intellectual Property Rights in order to contribute to innovation and promote
public health. There are three projects for innovation with the World Intellectual
Property Organization (WIPO): TISC, TTO, IP Academy.
4.2 Manufacturing There are 119 licensed pharmaceutical manufacturers in Egypt. Manufacturing
capabilities are presented in Table 5 below.
Table 5: Egypt manufacturing capabilities20
Manufacturing capabilities
Research and Development for discovering new active substances No
Production of pharmaceutical starting materials (APIs) Yes
The production of formulations from pharmaceutical starting material Yes
The repackaging of finished dosage forms Yes
Section 5 – Medicines Regulation
This section details the pharmaceutical regulatory framework, resources,
governing institutions and practices in Egypt.
5.1 Regulatory Framework In Egypt, there are legal provisions establishing the powers and responsibilities
of the Medicines Regulatory Authority (MRA). The MRA is a part of the MoH with
a number of functions outlined in Table 6. The MRA has its own website, for
which the URL address is www.eda.mohp.gov.eg. The Egyptian Drug Authority
(EDA) is the pharmaceutical regulatory body of the Egyptian Ministry of Health.
EDA has three sub-organizations: CAPA, NODCAR, NORCB.10
Table 6: Functions of the national MRA15
Function
Marketing authorisation / registration Yes
Inspection Yes
Import control Yes
Licensing Yes
Market control Yes
Quality control Yes
Medicines advertising and promotion Yes
Clinical trials control No
Pharmacovigilance Yes
As of 2011, there were 820 permanent staff working for the MRA (CAPA). The
MRA receives external technical assistance to support its activities (technical
committees formed of external professors).15 The MRA is not involved in
harmonization/collaboration initiatives. An assessment of the medicines
regulatory system has been conducted in the last five year. # Funding for the
MRA is provided through the regular government budget as well as through fees
from services provided. The Regulatory Authority retains 50% of revenues
derived from regulatory activities. This body utilizes a computerized information
management system to store and retrieve information on processes that include
registrations, inspection etc15.
5.2 Marketing Authorization (Registration) In Egypt, legal provisions require marketing authorization (registration) for all
pharmaceutical products on the market, however exceptions/waivers for
registration do exist. Mutual recognitions mechanisms are in place: under certain
requirements: for prescriptions only, reports from physicians, through an
Egyptian drug distribution company15. Explicit and publicly available criteria exist
for assessing applications for marketing authorization of pharmaceutical
products15. In 2011, there were 8973 pharmaceutical products registered in
Egypt. There are legal provisions requiring the MRA to make the list of registered
pharmaceutical products publicly available and update it regularly. This register is
updated every 10 years. The updated list can be accessed through
http://www.eda.mohealth.gov.eg/Services/Drug_Hum.aspx?Main=Services&Servi
ceid=2&Submain=serv7. Medicines are always registered by their INN
(International Non-proprietary Names) or Brand name + INN. Legal provisions
require a fee to be paid for Medicines Market Authorization (registration) based
on applications15.
Marketing Authorization holders are required by law to provide information about
variations to the existing Marketing Authorization. Legally, a Summary of
Product Characteristics (SPC) of the medicines that are registered is required to
be published. Furthermore, legal provisions requiring the establishment of an
expert committee involved in the Marketing Authorization process are in place.28
Possession of a Certificate for Pharmaceutical Products (that accords with the
WHO Certification scheme) is not required as part of the Marketing Authorization
application. By law, potential conflict of interests for experts involved in the
assessment and decision-making for registration must be declared. Applicants
may legally appeal MRA decisions.
The registration fee (per application) for a pharmaceutical product containing a
New Chemical Entity (NCE) and for fee for generic pharmaceutical products is
US$ 1,675.21
The time limit imposed for the assessment of all Marketing Authorization
applications is 12 months.
5.3 Regulatory Inspection In Egypt, legal provisions exist allowing for appointment of government
pharmaceutical inspectors22. Legal provisions exist permitting inspectors to
inspect premises where pharmaceutical activities are performed, such
inspections are required by law and are a pre-requisite for the licensing of public
and private facilities.13 Where inspections are legal requirements, these are the
same for public and private facilities. Exception: 1) The expired drugs in the
public facilities are not present however in private facilities they are present in
isolated places until they are returned to suppliers. 2) Inspection on inventory
present in public facilities. 23 Inspections are carried out on a number of entities,
outlined in Table 7.
Table 7: Local entities inspected for GMP compliance13
Entity Inspection Frequency
Local manufacturers Yes
Private wholesalers Yes
Retail distributors Yes
Public pharmacies and stores Yes
Pharmacies and dispensing points if health facilities Yes
5.4 Import Control Legal provisions exist requiring authorization to import medicines. Laws exist that
allow the sampling of imported products for testing.
Legal provisions exist requiring importation of medicines through authorized ports
of entry. Regulations or laws do not exist to allow for inspection of imported
pharmaceutical products at authorized ports of entry24.
5.5 Licensing In Egypt, legal provisions exist requiring manufacturers to be licensed13. Legal
provisions exist requiring manufacturers (both domestic and international) to
comply with Good Manufacturing Practices (GMP). Good Manufacturing
Practices are published by the government25.
Legal provisions exist requiring importers/wholesalers/distributers to be
licensed.23 Legal provisions exist requiring wholesalers and distributors to comply
with Good Distributing Practices.23 26
Table 8: Legal provisions pertaining to licensing
Entity requiring licensing
Importers Yes
Wholesalers Yes
Distributors Yes
Good Distribution Practices are published by the government23.
Legal provisions requiring pharmacists to be registered exist. Legal provisions
exist requiring private and public pharmacies to be licensed27. National Good
Pharmacy Practice Guidelines are published by the government15. By law, a list
of all licensed pharmaceutical facilities is required to be published.
5.6 Market Control and Quality Control In Egypt, legal provisions exist for controlling the pharmaceutical market28. A
laboratory exist in Egypt for Quality Control testing15.
The laboratory is a functional part of the MRA.
The regulatory authority contracts services elsewhere (The National Organization
for Research & Control of Biologicals)
Existing national laboratory facilities have been accepted for collaboration with
the WHO pre-qualification Programme – National Organization for Drug Control
and Research (NODCAR)29. Medicines are tested for a number of reasons,
summarised in Table 9.
Table 9: Reason for medicines testing28
Medicines tested:
For quality monitoring in the public sectoriii Yes
For quality monitoring in the private sectoriv Yes
When there are complaints or problem reports Yes
For product registration Yes
For public procurement prequalification Yes
For public program products prior to acceptance and/or distribution Yes
Samples are collected by government inspectors for undertaking post-marketing
surveillance testing13.
In the past 2 years, 48,706 samples were taken for quality control testing. Of the
samples tested, 277 (or 0.57 %) failed to meet the quality standards.30 The
results are not publicly available.
iii Routine sampling in pharmacy stores and health facilities iv Routine sampling in retail outlets
5.7 Medicines Advertising and Promotion In Egypt, legal provisions exist to control the promotion and/or advertising of
prescription medicines. The Medicines Regulatory Authority (Central
Administration for Pharmaceutical Affairs) is responsible for regulating promotion
and/or advertising of medicines. Legal provisions prohibit direct advertising of
prescription medicines to the public and pre-approval for medicines
advertisements and promotional materials is required.13 31 Guidelines and
Regulations exist for advertising and promotion of non-prescription medicines.32
There is no national code of conduct concerning advertising and promotion of
medicines by marketing authorization holders.
5.8 Clinical Trials In Egypt, legal provisions requiring authorization for conducting Clinical Trials by
the MRA do not exist. There are no additional laws requiring the agreement by
an ethics committee or institutional review board of the Clinical Trials to be
performed. Clinical trials are not required to be entered into an
international/national/regional registry, by law.
Legal provisions do not exist for GMP compliance of investigational products.
Sponsor investigators are not legally required to comply with Good Clinical
Practices (GCP). National GCP regulations are not published by the Government.
Legal provisions do not permit the inspection of facilities where clinical trials are
performed.
5.9 Controlled Medicines Egypt is a signatory to a number of international conventions, detailed in Table
10.
Table 10: International Conventions to which Egypt is a signatory33
Convention Signatory
Single Convention on Narcotic Drugs, 1961 Yes
1972 Protocol amending the Single Convention on Narcotic Drugs, 1961 Yes
Convention on Psychotropic Substances 1971 Yes
United Nations Convention against the Illicit Traffic in Narcotic Drugs and
Psychotropic Substances, 1988
Yes
Laws exist for the control of narcotic and psychotropic substances, and
precursors (Decree 350, EDA, available at:
http://www.eda.mohealth.gov.eg/Download/Docs/Decree350.pdf, Accessed: 20-
06-11). The annual consumption of Morphine is 0.2195122 mg/capita.33
The legal provisions and regulations for the control of narcotic and psychotropic
substances, and precursors have not been reviewed by a WHO International
Expert or Partner Organization to assess the balance between the prevention of
abuse and access for medical need.
Figures regarding the annual consumption of certain controlled substances in the
country are outlined in Table 10S below.
Table 10S: Annual consumption of selected controlled substances in Egypt34
Controlled substance Annual consumption (mg/capita)
Morphine 0.2195122
Fentanyl 0.02439024
Pethidine 1.09756098
Oxycodone 0.0304878
Hydrocodone 0.06097561
Phenobarbital 73.1707317
Methadone 0.01219512
5.10 Pharmacovigilance In Egypt, there are legal provisions in the Medicines Act that provide for
pharmacovigilance activities as part of the MRA mandate.35 Legal provisions also
exist requiring the Marketing Authorization holder to continuously monitor the
safety of their products and report to the MRA.36 Laws regarding the monitoring
of Adverse Drug Reactions (ADR) exist in Egypt. The reporting of ADR by
healthcare professionals is optional.35 A national pharmacovigilance centre
linked to the MRA exists.36
The Pharmacovigilance centre has 7 full-time staff members (6 pharmacists, 1
administrative assistant).
The centre has not published an analysis report in the previous two years. It
publishes an ADR bulletin. An official standardized form for reporting ADRs is
used in Egypt. Information pertaining to ADRs is stored in a national ADR
database. The ADR database currently comprises 91 ADR reports, of which 91
have been submitted in the past 2 years. These reports are not sent to the WHO
collaborating centre in Uppsala37.
There is a national ADR or pharmacovigilance advisory committee able to
provide technical assistance or causality assessment, risk assessment, risk
management, case investigation and, where necessary, crisis management
including crisis communication in Egypt.36 A clear communication strategy for
routine communication and crises communication does not exist.
ADRs are not monitored in any public health program (example TB, HIV, AIDS).
A number of steps are being considered in order to enhance the
Pharmacovigilance system. These include:
• recruiting and training more staff
• finalize the regulatory pharmacovigilance guidelines
• implementation of pharmacovigilance training on large scale for
pharmaceutical companies and healthcare professionals
• expanding the awareness campaign to all governorates
• expand speciality of EPVC to include medication errors
Section 6 - Medicines Financing
In this section, information is provided on the medicines financing mechanism in
Egypt, including the medicines coverage through public and private health
insurance, use of user charges for medicines and the existence of public
programmes providing free medicines. Policies and regulations affecting the
pricing and availability of medicines (e.g. price control and taxes) are also
discussed.
6.1 Medicines Coverage and Exemptions In Egypt, concessions are made for certain groups to receive medicines free of
charge (see Table 12). Furthermore, the public health system or social health
insurance schemes provide medicines free of charge for particular conditions
(see Table 13).
Table 12: Population groups provided with medicines free of charge38
Patient group Covered
Patients who cannot afford them Yes
Children under 5 Yes
Pregnant women No
Elderly persons Yes
Table 13: Medications provided publicly, at no cost38
Conditions Covered
All diseases in the EML Yes (EML of HIO)
Any non-communicable diseases No
Malaria Yes
Tuberculosis Yes
Sexually transmitted diseases No
HIV/AIDS No
Expanded Program on Immunization (EPI) vaccines
for children
Yes
Other – bilharzias, hepatitis C Yes
Medicines are provided free of charge because they are related to endemic
diseases in Egypt.39
A public health service, public health insurance, social insurance or other
sickness fund provides at least partial medicines coverage.
It provides coverage for medicines that are on the Essential Medicines List (EML)
for inpatients and outpatient.
There are four classes for HIO beneficiaries:
1) Employees covered through Law 32 of the year 1957 (all employees
working in the government sector)
2) Employees covered through Law 79 of 1957 (some public and private
sector employees, pensioners, widows)
3) Beneficiaries of the Student Health Insurance Program (SHIP) by law
number 99 for year 1992 and covering more than 14 million students, thus
increasing the total beneficiary population from 4.895 million in 1992 to
20.67 million in 1995. (Egypt National Health Accounts, 1995).
4) Newly-born children up to age five years, according to ministerial decree
number 380 for the year 1997an action that has increased the beneficiary
population by some 9 million, to include approximately 55% of the
Egyptian population.
Private health insurance schemes provide medicines coverage.12
They are required to provide at least partial coverage for medicines that are on
the EML.
6.2 Patients Fees and Co-payments Co-payments or fee requirements for consultations are not levied at the point of
delivery. There are copayments or fee requirements imposed for medicines.
Revenue from fees or from the sale of medicines is not used to pay the salaries
or supplement the income of public health personnel in the same facility.
6.3 Pricing Regulation for the Private Sectorv In Egypt, there are legal or regulatory provisions affecting pricing of medicines40.
These provisions are aimed at the level of manufacturers/wholesalers/retailers.
These provisions are applied to all types of medicines in the market (generic,
originator EML).
The government runs an active national medicines price monitoring system for
retail prices.41 Regulations exist mandating that retail medicine price information
should be publicly accessible42. (CAPA Pricing Committee, see
http://www.eda.mohealth.gov.eg/Services/CAPAComm.aspx?Main=Services&Se
rviceid=2&Submain=serv30)
v This section does not include information pertaining to the non-profit voluntary sector
6.4 Prices, Availability and Affordability of Key Medicines In 2004, a WHO/HAI pricing survey was conducted in Egypt43. Table 13 provides
specific details regarding availability, pricing and affordability in the country.
Availability Public sector availability of originator medicines was 100 %, while availability of
the Lowest priced generic (LPG) medicines was 100 %. Availability in the private
sector was 100 % for originator and 100 % for generics.
One explanation for high availability in the public sector is that Egypt has an
Essential Drug List which corresponds very well with the core list used in the
survey. Although a few essential medicines have been added by use of the
supplementary list, average availability remains high. Nevertheless, it has to be
remembered that the estimate is based on a one point in time investigation.
Pricing The Median Price Ratio is used to indicate how prices of medicines in Egypt
relate to those on the international market. That is, prices of medicines have
been compared to international reference pricesvi and expressed as a ratio of the
national price to the international price. For example, a price ratio of 2 would
mean that the price is twice that of the international reference price. Since prices
have been collected for a predefined basket of medicines, the Median Price Ratio
has been selected to reflect the situation in the country.
Public procurement prices: the Median Price Ratio for generics was 0.95. No
originators were found in the governmental sector. As for patient prices, the
Median Price Ratio in the public sector was 0.95 for generics, while the private
sector had higher prices (1.69 for generics, 2.73 for originators).
vi The International reference price is the median of prices offered by international suppliers (both for profit and not profit) as report by MHS International Price Indicator Guide (http://erc.msh.org/mainpage.cfm?file=1.0.htm&module=DMP&language=English). For more information on the methodology WHO/HAI pricing survey, you can download a free copy of the manual at http://apps.who.int/medicinedocs/documents/s14868e/s14868e.pdf.
Affordability Affordability of medicines is measured in terms of the number of days’ of wages
necessary to purchase a particular treatment for a specific condition. The wage
considered is that paid to the lowest paid government worker in Egypt. Specific
data collected for the survey underlying this profile examined the number of days’
wages required to purchase treatment with co-trimoxazole (note: data is for
amoxicillin, data for co-trimoxazole is not available) for a child respiratory
infection; The purchase of generic medication necessitated 0.3 days’ wages for
public patients and 0.5 for private patients. It is evident, therefore, that generic
medicines are less affordable in the private sector than in the public sector.
Table 14: Availability, Pricing and Affordability of medicines in Egypt
Public procurement Public patient Private
patient Availability
Mean (%) Originator 100% 100%
Lowest priced generic (LPG) 100% 100%
Median (%) Originator
Lowest priced generic (LPG)
Price
Mean Price
Ratio
Originator 2.73
Lowest priced generic (LPG) 0.95 0.95 1.96
Affordability
Number of
days’ wages
Originator
Lowest priced generic (LPG) 0.3 0.5
6.5 Price Components and Affordability In 2004, a survey on medicine price components was conducted in Egypt.43
There is not enough data available to complete this section.
6.6 Duties and Taxes on Pharmaceuticals (Market) Egypt imposes duties on imported active pharmaceutical ingredients (APIs) and
duties on imported finished products are imposed. Value-added tax or other
taxes are imposed on finished pharmaceutical products. Provisions for tax
exceptions or waivers for pharmaceuticals and health products are in place44.
Taxes are applied to all pharmaceuticals except that stated in the law 11 and
ministerial decree 314 regarding medicines of chronic diseases and products of
acdema companies (which are also duties free). Furthermore, all active
ingredients are tax free, but first their companies must apply to CAPA to release
ministerial decree including a list of this materials.
Section 7 - Pharmaceutical procurement and distribution in the public sector
This section provides a short overview on the procurement and distribution of
pharmaceuticals in the public sector of Egypt.
7.1 Public Sector Procurement Public sector procurement in Egypt is both centralized and decentralized.45
The public sector procurement is centralized under the responsibility of a
procurement agency which is part of MoH46. It is centralized for hospitals, health
units and Medical Convoys of MoH. The national procurement agency is not
responsible for the procurement of university hospitals which follow the Ministry
of Higher Education.
Public sector request for tender documents are publicly available and public
sector tender awards are publicly available. Procurement is based on the
prequalification of suppliers47. A team from the procurement department made an
inspection visit in 2007 to different drug suppliers. According to this
prequalification criteria then fed the data in a database in IT of MoH. Any supplier
must fill the required criteria in this database before the application to a
procurement process and any changes or addition regarding their data collected
in this database.
There is a written public sector procurement policy. This policy was approved in
1998. Legal provisions exist that give priority to locally produces goods in public
procurement. The key functions of the procurement unit and those of the tender
committee are not clearly separated.48 A process exists to ensure the quality of
products that are publicly procured. The quality assurance process includes the
pre-qualification of products and suppliers.
A list of pre-qualified suppliers and products is available.
A list of samples tested during the procurement process and the results of quality
testing are available. The tender methods employed in public sector
procurement include national competitive tenders.
7.2 Public Sector Distribution The government supply system department in Egypt has a Central Medical Store
at National Level also known as “General Administration of Medical
Supplement”49. There are 194 public warehouses in the secondary tier of the
public sector distribution. There are national guidelines on Good Distribution
Practices (GDP). A licensing authority that issues GDP licenses exists23 50.
The licensing authority does not accredit public distribution facilities.
A list of GDP certified wholesalers and distributors does not exist in the public
sector.
7.3 Private Sector Distribution
Legal provisions exist for licensing wholesalers and distributors in the private
sector. A list of GDP certified wholesalers and distributors exists in the private
sector50 51.
Section 8 - Selection and rational use of medicines This section outlines the structures and policies governing the selection of
essential medicines and promotion of rational drug in Egypt.
8.1 National Structures A National Essential Medicines List (EML) exists.
The EML was lastly updated in 2006 and is publicly available.
There are currently 500 medicines on the EML. Selection of medicines for the
EML is not undertaken through a written process. A mechanism aligning the
EML with the Standard Treatment Guidelines (STGs) is in place52.
National Standard Treatment Guidelines (STGs) for the most common illnesses
are produced/endorsed by the MoH in Egypt. These were last updated in 2010.
Specific STGs cover primary care (updated in 2008), secondary care (updated in
2006), and paediatric conditions (updated in 2010.11 52
Of the public health facilities, 41.2 % have a copy of the EML and 26.5 % have a
copy of the STGs.53
There is no public or independently funded national medicines information centre
providing information on medicines to prescribers, dispensers and consumers. A
survey on rational use of medicines has been conducted in the previous two
years54. There is a national programme or committee, involving government, civil
society, and professional bodies, to monitor and promote rational use of
medicines.
A written National Strategy for containing antimicrobial resistance does not exist.
Egypt’s Essential Medicines List (EML) includes formulations specifically for
children. Criteria for the selection of medicines to the EML not explicitly
documented.10 A national medicines formulary does exist.
A funded national intersectoral task force to coordinate the promotion of the
appropriate use of antimicrobials and prevention of the spread of infection exists.
A national reference laboratory or other institution does not have responsibility for
coordinating epidemiological surveillance of antimicrobial resistance.
8.2 Prescribing Legal provisions exist to govern the licensing and prescribing practices of
prescribers. Furthermore, legal provisions restricting dispensing by prescribers
exist. Prescribers in the private sector do dispense medicines.9
There are regulations requiring hospitals to organize/develop Drug and
Therapeutics Committees (DTCs)13.
The training curriculum for doctors and nurses is made up of a number of core
components detailed in Table 16.
Table 16: Core aspects of the medical training curriculum
Curriculum Covered
The concept of EML No
Use of STGS Yes
Pharmacovigilance Yes
Problem based pharmacotherapy Yes
Mandatory continuing education that includes pharmaceutical issues is not
required for doctors/nurses/paramedical staff.
Prescribing by INN name is obligatory in the public sector.13 The average number
of medicines prescribed per patient contact in public health facilities is 2.3. Of
the medicines prescribed in the outpatient public health care facilities, 88.47 %
are on the national EML and 37.5 % are prescribed by INN name. Of the
patients treated in the outpatient public health care facilities, 49.8 % receives
antibiotics and 13.2 % receive injections. Of prescribed drugs, 91.2 % are
dispended to patients. Of medicines in public health facilities, 45.2 % are
adequately labelled.
Table 17: Characteristics of medicines prescribing
Curriculum %
% of medicines prescribed in outpatient public health care facilities that
are in the national EML (mean)
88.47
% of medicines in outpatient public health care facilities that are
prescribed by INN name (mean)
37.5
% of patients in outpatient public health care facilities receiving
antibiotics (mean)
49.8
% of patients in outpatient public health care facilities receiving
injections (mean)
13.2
% of prescribed drugs dispensed to patients (mean) 91.2
% of medicines adequately labeled in public health facilities (mean) 45.2
A professional association code of conduct which governs the professional
behaviour of doctors exists.9
8.3 Dispensing
Legal provisions in Egypt exist to govern dispensing practices of pharmaceutical
personnel.10 The basic pharmacist training curriculum includes a spectrum of
components as outlined in Table 18.
Table 18: Core aspects of the pharmacist training curriculum
Curriculum Covered
The concept of EML No
Use of STGS Yes
Drug information Yes
Clinical pharmacology Yes
Medicines supply management No
Mandatory continuing education that includes rational use of medicines is not
required for pharmacists.
Substitution of generic equivalents at the point of dispensing is allowed in public
and private sector facilities13. Sometimes antibiotics are sold over-the-counter
without a prescription. Sometimes injectable medicines are sold over-the-
counter without a prescription.
A professional association code of conduct which governs the professional
behaviour of pharmacists exists.8
List of key reference documents: 1 World Health Organization (WHO) (2011), “World Health Statistics 2011”, WHO Press, Geneva.
Available online: http://www.who.int/whosis/whostat/2011/en/index.html.
2 World Health Organization (WHO) (2009), “World Health Statistics 2009”, WHO Press, Geneva.
Available online: http://www.who.int/whosis/whostat/2009/en/index.html.
3 World Bank data for Egypt, 2009. Available at: http://data.worldbank.org/country/egypt-arab-
republic, 30-06-2011. 4 NHA 2009, MOH 2011 5 Calculated based on data provided in WHS 2011 and NHA 2007-2008 6 Calculated based on data provided in WHS 2011 and NHA 2007-2008 7 National Health Accounts Egypt 2007-2008, Available at:
http://www.who.int/nha/country/egy/en/,30-06-2011.
8 Egyptian Pharmacists Syndicate, 2011. Available at: http://www.egypharmsynd.org, Code of
Conduct: http://egypharmsynd.org/files/h6.jpg, 30-06-2011. 9 Egyptian Medical Syndicate, 2011.Available at: http://www.ems.org.eg/, 30-06-2011.
10 Central Administration of Pharmaceutical Affairs (CAPA) at Ministry of Health, Department of
QA and Training, www.eda.mohp.gov.eg, Dr. Heba Mostafa (Tel. 25354100), 06-2011.
11 data/information provided by MOH Egypt, 2011. 12 Health System Profile Egypt, EMR Health Sytem Observatory, WHO, 2006. Available at:
http://gis.emro.who.int/HealthSystemObservatory/PDF/Egypt/Full%20Profile.pdf, 30-06-2011.
13 World Health Organization (WHO) (2007), WHO Level 1 Survey, Geneva. 14 Pharmacy policies and procedures, Health Insurance Information (Arabic only), 2009.
http://www.mohp.gov.eg/DocLib6/Pharmacy%20policies%20_%20procedures.pdf; 30-06-2011. 15 Egyptian Drug Authority at Ministry of Health, available at: www.eda.mohp.gov.eg,
http://www.eda.mohp.gov.eg/About/EDAWelcome.aspx?Main=about&aboutid=1&SubAbout=55,
External technical assistance, Marketing Authorization, see Decree 296,
http://www.eda.mohp.gov.eg/Download/Docs/MinisterDec296.pdf (Arabic only).
Funding and revenues see Decree 26,
http://www.eda.mohp.gov.eg/Download/Docs/Decree_26_2009.pdf (Arabic only).
Registration:http://www.eda.mohealth.gov.eg/Services/Drug_Hum.aspx?Main=Services&Servicei
d=2&Submain=serv7, 30-06-2011.
16 Law 47 for Civilian personnel system state 2011.
17 World Trade Organization (WTO). Available at: www.wto.org.
18 Egyptian Patent Office, Technology Development and Scientific services sector, Academy of
Scientific Research & Technology (ASRT), Available at: www.egypo.gov.eg.
19 Intellectual Property Law No. 82, 2002. Available at:
http://www.egypo.gov.eg/inner/english/PDFs/law2002e.pdf, 30-06-2011.
20 Pharmaceutical Licensing Administration, Central Administration of Pharmaceutical Affairs
(CAPA),Ministry of Health. (see ref n 14) 21 Minister Decree No. 26/2009: Fees of Services provided by CAPA, EDA, available at http://www.eda.mohp.gov.eg/Download/Docs/Decree_26_2009.pdf , 2011-12-20. 22 Decree 281, EDA website, 23 Minister Decree No. 25/2009: Regulations of Wholesale Stores, available
http://www.eda.mohp.gov.eg/Download/Docs/New_Minister_Decree_for_Wholesalers.pdf
24 Decree 132, EDA,
25 Decree 539, EDA,
http://www.eda.mohealth.gov.eg/Download/Docs/Minister_Decree_539_Both.pdf, 26 Minister Decree for Wholesalers,
http://www.eda.mohealth.gov.eg/Download/Docs/New_Minister_Decree_for_Wholesalers.pdf
27 EDA Website: regarding legal provision requiring pharmacists to be registered, see EDA
website, available at:
http://www.eda.mohp.gov.eg/Services/Pharma_Services.aspx?Main=Services&Serviceid=1&Sub
main=serv3 (Pharmacists Certificates, available in Arabic);
Licensing of public pharmacies, see http://www.eda.mohp.gov.eg/Download/Docs/380.pdf
(available in Arabic) 28 Minister Decree No. 296/2009: Registration of Human Drugs, EDA, available at:
http://www.eda.mohp.gov.eg/Download/Docs/MinisterDec296.pdf (Arabic only).
29 Information provided by CEO of NODCAR (2011) 30 NODCAR report 2011, Available at NODCAR. 31 Decree 106 32
33 Report of the International Narcotics Control Board for 2009, Vienna, International Narcotics
Control Board (INCB), 2009. Available at: www.incb.org, 08-06-2010.
34 International Narcotics Control Board for (2009) 35 Minister Decree 397 36 Minister Decree 2
37 Egyptian Pharmacovigilance Center (EPVC), http://www.epvc.gov.eg/, form for reporting ADRs
available at: http://www.epvc.gov.eg/images/Downloads/F_12.pdf
38 Health Insurance Organisation (HIO), Law 79 for year 1975 for pensioners
Law 32 for year 1975 for government employees
Law 99 for year 99 for students
Law 380 for year 1997 for neonates. 39 Information provided by Dr Monier Shokry (MOH) (2011) 40 Ministerial Decree 373 for year 2009
314 for year 1992
38 for year 1993
150 for year 1990
313 for year 1991; 41 According to Law 108 from 1980.
42 CAPA Pricing Committee, available at:
http://www.eda.mohealth.gov.eg/Services/CAPAComm.aspx?Main=Services&Serviceid=2&Subm
ain=serv30,
43 Survey Report of the prices people have to pay for medicines in Egypt, WHO/HAI pricing
survey Egypt, available at: www.haiweb.org/medicineprices/related/200407_Egypt.pdf, 20-06-11
44 Law 118 for 1975
Law 11 for year 1991,
Presidential Decree No. 113/1962, available at:
http://www.eda.mohp.gov.eg/Download/Docs/Presdential_Decree_113-1963.pdf ;
Decree 314 for year 1992,
Decree 321 for year 2010,
Decree 709 for year 1978;
45 Headline of Tender Condition Booklet.
46 Information provided by Dr Rasha Aboshady, Head of the Procurement Department (2011)
47 Prequalification Criteria, 2007, according Dr Rasha Aboshady, Head of the Procurement
Department, 2011. 48 The law of tenders and auctions 89 for year 1998. 49 Dr Mohammed Ali, Manager of General Administration of Medical Supplement
50 Minister Decree No. 380/2009: Specifications of Pharmacies and Stores, available at:
http://www.eda.mohp.gov.eg/Download/Docs/380.pdf , 20-1-2012
51 Pharmacy Law 127 for year 1955, code 40-45. 52 WHO Level 1 survey (2006) and The reference is Central Administeration of Pharmaceutical Affairs (CAPA) - procurement department. The responsible person is Dr. Rasha Aboshady (2011). There is a mechanism to align the EML with the (STG) especially in oncology medicines.
There is committee on facilities level to monitor drugs utilization, following of clinical guidelines
beginning in 2002 and still until now. 53 WHO essential drugs and medicines policy (2008) 54 Central Administration of Pharmaceutical Affairs (CAPA)-EPVC-MOH (2010)
Pharmaceutical Sector Country Profile
Questionnaire
EGYPT
Pharmaceutical Sector Country Profile Questionnaire. Final Version. Page 2
The Pharmaceutical Sector Country Profile Survey
1. Background and Rationale:
Pharmaceutical Sector Country Profiles aim to increase the availability of quality information on structures, processes
and outcomes of health and pharmaceutical sectors of countries. This information will be collected through a
questionnaire and is meant to be used by country decision-makers, health and pharmaceutical experts, international
partners and the public through databases and published country, regional and global reports.
The information is categorized in nine sections, namely: (1) Health and Demographic data, (2) Health Services, (3)
Medicines Policies, (4) Medicines Trade and Production, (5) Medicines Regulation, (6) Medicines Financing, (7)
Pharmaceutical Procurement and distribution, (8) Selection and Rational Use and (9) Household data/access.
Every four years since 1999, health officials from the 193 WHO Member States have been invited to complete a
standardized questionnaire (named Level I) reporting on the status of the national pharmaceutical situation. Level I
indicators assessed structures and processes related to the pharmaceutical situation of a country. They were used to
carry out a rapid assessment that would highlight strengths and weaknesses of countries pharmaceutical situations.
156 countries responded to the 2007 level I survey and the results were stored and available in a global WHO
database and used to develop a global report as well as a number of regional and sub-regional reports. The
Pharmaceutical Sector Country Profile questionnaire described here will replace the Level I tool for the 2011 Member
States' survey. The aim of this new approach is to build on the achievements and lessons learnt from the Level I tools
and surveys and to improve the quality and scope of information (e.g, outcomes and results indicators) and enhance
the involvement and ownership of countries in the development of profiles. The new tool has been piloted in the 15
countries of the Southern African Development Community in 2009 and in 13 countries across the world in 2010. The
results of these pilots are available on-line at:
http://www.who.int/medicines/areas/coordination/coordination_assessment/en/index.html
Another innovation of the 2011 survey is the collaboration between WHO and The Global Fund. In 2009, the Global
Fund developed and introduced the Pharmaceutical and Health Product Management ("PHPM") Country Profile to
gradually replace the Procurement and Supply Management ("PSM") Plan. In the course of 2010 both agencies have
developed a joint Pharmaceutical Sector Country Profile questionnaire that includes key indicators of the
Pharmaceutical Sector Country Profile Questionnaire. Final Version. Page 3
pharmaceutical sector and that will be used by both agencies as the sole tool for pharmaceutical sector data
collection in countries. The information captured in the Pharmaceutical Sector Country Profile questionnaire will be
used by the Global Fund during grant negotiations and signing, and will also support grant implementation. In
addition to the Country Profile that provides an overview of countries' pharmaceutical sectors, the Global Fund will
also use a second questionnaire that will focus in more detail on medicines procurement and supply.
2. What can Pharmaceutical Sector Country Profiles offer:
Completing this questionnaire will require the time of national experts and responsible officers but it is worthwhile as
your country and your partners will benefit from it in a number of ways:
I) The questionnaire offers a unique opportunity to consolidate, in one place, information that is available in
different locations and institutions e.g. the National Medicines Regulatory Authority, Central Medical Stores,
National Health Accounts, etc.
II) The methodology proposed for filling in the questionnaire will ensure that good quality data are collected and
that the source and date of information are known and reported.
III) Data on structure, process and outcomes are collected, and the questionnaire has been pre-filled with data
available in the public domain; indicators are divided into core and supplementary in order to make it easier
to identify what is more important.
IV) The data collected will highlight the strengths and weaknesses of the pharmaceutical sector and will be made
available in a national database as official country information, for use by decision-makers, health and
pharmaceutical experts, researchers and international partners and the public..
V) The data collected could be transformed into a narrative report with robust data analysis and bibliographic
references, that will summarize the medicines situation in the country.
VI) Based on experiences from previous surveys, a detailed glossary of key definitions and a manual for use of the
questionnaire have been developed and can be found at the end of the questionnaire.
Pharmaceutical Sector Country Profile Questionnaire. Final Version. Page 4
3. The process of data collection and analysis:
3.1 Data collection. The Pharmaceutical Sector Country Profile questionnaire has already been filled in by WHO with
reliable data available from global and country sources. We kindly ask you to review, to correct (if necessary) and to
validate the information already included in the questionnaire, and also to fill in the gaps, based on reliable
information available in your country.
In order to do this, we recommend that you involve the most appropriate respondents and responsible institutions to
fill in the various components of the tool so that the questionnaire is completed within the given deadline, with good
quality information. If during the data collection process, clarifications are needed, WHO Regional and Headquarters
Offices will provide the necessary assistance and support, including for data quality issues.
3.2 Official endorsement. Once the questionnaire has been
completed, the information contained in it should be
officially endorsed and its disclosure authorized by a senior
official in the Ministry of Health. This should be done by
signing the formal endorsement form attached to the
questionnaire. This will ensure that the quality of the
information contained in the Pharmaceutical Sector
Country Profile questionnaire is certified by the country.
3.3 Data shared with the Global Fund. Data collected from
Global Fund priority countries will be shared with the
Global Fund and it will be used as part of the Global Fund's
own grant signing and implementation procedures.
3.4 Data posted on key databases. Data endorsed by the
country will be posted on health databases (such as the
WHO Global Health Observatory,
http://www.who.int/gho/en/), making it available to
decision-makers, health and medicines experts and
researchers, international partners and the public.
Pharmaceutical Sector Country Profile Questionnaire. Final Version. Page 5
3.5 Development of narrative Pharmaceutical Sector Country Profiles. Data provided within the country
questionnaire can be used by the country to develop a narrative profile that will illustrate the national
pharmaceutical sector. In order to do this, WHO has prepared a template profile (included in the CD-Rom shared with
you) that can be easily used by countries and that will help presenting data in the form of tables, graphs and charts.
Countries could seek support from WHO for the development of their narrative profile, which will be finalized and
validated by the country that will own the copyright for it and will publish it as a national official document.
3.6 Development of Regional and Global Reports. The information provided by countries in the Pharmaceutical
Sector Country Profile questionnaire will be analysed by WHO and used to produce regional and global reports on the
pharmaceutical sector of countries in 2011. These reports will provide an overview of the progress made between
2007 and 2011, of the challenges that remain to be addressed and will include data analysis by technical areas,
countries' income level and geographical location.
Pharmaceutical Sector Country Profile Questionnaire. Final Version. Page 6
Guidelines for countries on how to fill in the Pharmaceutical Sector
Country Profile Questionnaire
Please read these instructions carefully before starting data collection
1. Macros: the questionnaire has macros installed. A macro is a series of MS Word commands and instructions that
are grouped together as a single command to accomplish a task automatically. For these macros to work properly,
the macro security levels for MS Word on your computer should be set as 'low'. This can be easily adjusted by taking
the following steps:
1. Open the Word document containing the instrument.
2. Go to 'Tools' > 'Macro' > 'Security'.
3. Click on the tab 'Security Level'.
4. Set the Security on 'Low' and click 'OK'.
After filling in the questionnaire, the setting should be restored to a higher level of security in order to protect your
computer.
2. Core and supplementary indicators: the instrument consists of core and supplementary questions. Core questions
cover the most important information, while supplementary questions deal with more specific information applicable
to particular sections. Please note that core questions have been shaded with different coloured backgrounds for
different sections of the instrument, while supplementary questions are all white. This should help you to distinguish
between the different categories of indicators. Please try to fill in all the core questions for each section before
moving to the supplementary ones. Remember that we are only asking you to collect information that is already
available and you are not expected to conduct any additional survey(s).
3. Prefilled data: the answers to some of the questions have been prefilled by WHO HQ. Where this is the case, please
verify this information as it may not be up-to-date. If you find that any of the prefilled responses are not correct,
please change the value and document the source and year.
Pharmaceutical Sector Country Profile Questionnaire. Final Version. Page 7
4. Calculated fields: for a few items, you will not be required to enter any value as these will be generated at WHO HQ
using data entered into related fields. These fields have been clearly marked in red – please do not input any data
into them or change data that are already in this field. For example, the per capita expenditure on health will be
automatically calculated once the total health expenditure and population are entered into the questionnaire. This
system is intended to improve the quality of answers and avoid you having to perform additional calculations.
Calculated fields are protected and cannot be changed.
5. Possible answers:
Checkbox 'Yes/No/Unknown': tick one of the three options (only one answer is possible).
Multiple choice checkbox: tick any of the options that apply (multiple answers are sometimes possible).
Percentage fields: 0-100. Please use decimal points ('dots') for decimals (example: 98.11). Please do not use ranges
(e.g. "3-5"). If you only have ranges, then use the median and otherwise the mean. In this instance, please detail what
data you have used and what the range is in the comment boxes.
Number fields: unlimited number. Please use decimal points ('dots') for decimals (example: 29387.93). Please do not
use ranges. If you only have ranges, then use the median and otherwise the mean. In this instance, please detail what
data you have used and what the range is in the comment boxes.
6. Comments: comments fields allow the entry of free text to clarify or follow up on answers given. Please reference
each comment by using the number of the question you are referring to (example: 2.01.02).
7. Year of data : year fields should be used to specify the year of the data used to answer the question. Only values
between 1930 and 2011 will be accepted. Please use this column as follows:
- When the source refers directly to a specific document (for example: 'Medicines Act' or 'EML'), please put in
the publication year of the document (note: only the year and not a specific date can be entered).
- When the source refers to a document that contains older data than the document itself, please put in the
original year of the data. For example, when the total population for 2008 is extracted from the World Health
Statistics 2010, please put 2008 in the 'year' column and 'World Health Statistics 2010' in the 'source' column.
- When the source of the information is not a document, but the informant himself/herself, please put in the
current year.
Pharmaceutical Sector Country Profile Questionnaire. Final Version. Page 8
eferenced in the narrative country profile and in wers given will be rans ources used for thes :of data Source8.
the databases in which the information will be stored. Please specify your sources as clearly as possible by
providing the name, year, and writer/publisher of the documents used. Also provide a web (URL) link to the
documents, if available. If there is only a non-English version of the reference available, then please include it
regardless of the language. Use the 'source' column to enter the name and year of the source, and use the
"Comments and References" fields at the end of every section to list the sources. In case the source is not
documented, then provide the name and title of the person and/or the entity they work for as a source of
information. Examples are given below.
9. Documents: you will see in the questionnaire that we would like you to collect and share a number of key country
documents that we believe would greatly enrich the country’s profile content and these documents could be made
available through countries and WHO web pages. Please attach the following documents, if available:
- National Medicines Policy (NMP);
- NMP implementation plan;
- National Medicines Act;
- National pharmaceutical Human Resources report or strategic plan;
- Latest report on the national pharmaceutical market (any source);
- Pharmacovigilance national centre report (including an Adverse Drug Reaction (ADR), analysis report
produced in the last two years);
- National pharmaceutical legislation or regulation;
- Annual report of quality control laboratories;
Pharmaceutical Sector Country Profile Questionnaire. Final Version. Page 9
- Annual report of national regulatory authority;
- Legal provisions on medicines price regulations;
- Medicines procurement policy;
- National Essential Medicines List (EML);
- National Standard Treatment Guidelines (STGs);
- National strategy for antimicrobial resistance;
- Any other medicines pricing/availability surveys, household surveys and rational use surveys, in addition to
the ones used to prefill the instrument.
The last page of the questionnaire contains a table with the list of key documents to be attached. Please fill it in by
indicating the exact title, publisher and year for each attachment as shown in the example below.
These documents will be published on the WHO web site's medicines library (http://apps.who.int/medicinedocs/en/ )
and will therefore have to be endorsed by the Ministry of Health prior to being made publicly available. You can send
us these documents by e-mail as attachments or you can upload them into a protected web site. Please use the table
at the end of the instrument to report the title, year and author of the documents attached.
10. Attaching files to the questionnaire: please place all files to be attached in a single folder on your computer. Name
the documents as follows: <short name of the document>.doc (example: EML.doc). Then compress (ZIP) the files and
attach the compressed file with the completed instrument to the email. If the total file size of the compressed file
exceeds 7 MB, you can upload the documents in a protected file server called MedNet, which is managed by WHO.
The procedure for doing this is very simple and please contact Mr Enrico Cinnella in WHO HQ, Geneva,
([email protected]) to be granted access to MedNet and to receive instructions on how to upload files. You can also
upload documents to the WHO Medicines Documentation server at http://hinfo.humaninfo.ro/medicinedocs/,
though the documents will only appear on the Medicines Documentation site at the beginning of the following month.
Document Exact title Author Publisher Year File name
Essential Medicines List National
Medicines List
Ministry of
Health
Ministry of
Health
2009 EML.doc
National Medicines
Policy
National Drug
Policy
Federal Ministry
of Health
Federal Ministry
of Health
2005 NDP.pdf
Pharmaceutical Sector Country Profile Questionnaire. Final Version. Page 10
11. Manual for use of the questionnaire: the manual contains detailed instructions on the questionnaire, on where to
find information and how to answer questions.
Questions that may be particularly problematic are marked with the following icon:
12. Glossary: the glossary contains definitions for all key and/or problematic items in the instrument. It is highly
recommended that you use the glossary, since exact definitions might differ between countries and institutions. The
glossary is at the end of the file. When a question contains an item that is defined in the glossary, the terms will be
marked in bold, underlined and written in blue font.
13. Respondents and acknowledgements: at the beginning of every section there are fields available to fill in details
about the respondent for that particular section. It is also possible to enter the details of multiple respondents. At the
end of the instrument please add a list of contributors who should be acknowledged. Provide their names and the
main organization(s) they work for.
14. Endorsement of data: A formal endorsement needs to be signed by a senior official in the Ministry of Health
before the completed questionnaire is sent back to WHO. The endorsement form is included in the pack of CD-ROM
documents you have received from WHO. Please present the endorsement form to a senior official in the Ministry of
Health for signature, and for obtaining permission to use and publish the data.
definition of "pharmaceutical
technicians and assistants" is in
the glossary
Instructions are available
for this specific question
Pharmaceutical Sector Country Profile Questionnaire. Final Version. Page 11
15. Process of creating a country profile document: The data you will collect using this questionnaire can be used to
develop a pharmaceutical sector country profile for the country. Examples of profiles are available on-line at
http://www.who.int/medicines/areas/coordination/coordination_assessment/en/index1.html
WHO has prepared a template profile (included in the CD) that can be easily used by countries and that will help
presenting data in the form of tables, graphs and charts. Countries can use the generic template provided by WHO
and add the information in the questionnaire. Below you can find an example of the template that shows how fields
can be changed according to the specific responses provided by each country.
In each section of the questionnaire you will find some comment boxes that you can use to expand on the answer to
one or more questions. The text of these comments can also be included in the profile in order to present the country
situation in more detail.
In the questionnaire you are also asked to indicate the source and date of each piece of information you provide;
these should be used to develop bibliographic references for the profile.
If you prefer, WHO can develop the narrative profile and the Organization will then share the document with the
country, which will own/maintain the copyright for it and will be able to publish it as a national document.
Pharmaceutical Sector Country Profile Questionnaire.
Section 0 General Info
0.01 Contact Info
0.01.01 Country (precoded) Egypt-RV
0.01.02 Name coordinator
0.01.03 Address (Street, City) 21 Abd-El-Aziz Al soud
0.01.04 Phone number +25354100
0.01.05 Email address [email protected]
0.01.06 Web address www.eda.mohealth.gov.eg
0.01.07 Institution Central Administration for Pharmaceutical Affairs (CAPA)
Pharmaceutical Sector Country Profile Questionnaire.
Section 1 Health and Demographic data
1.00 Respondent Information Section 1
1.00.01 Name of person responsible for filling
out Survey section 1
safa hassan nada
1.00.02 Phone number 0113535967
1.00.03 Email address [email protected]
1.00.04 Other respondents for filling out this
section
Information Center
Technical Office of Ministry of Health
1.01 Demographic and Socioeconomic Indicators
Core questions (click here for help)
Year Source
1.01.01 Population, total (,000) 82,999 2009 WHS2011
1.01.02 Population growth rate (Annual %) 1.9 2009 WHS2011
1.01.03 Total Gross Domestic Product (GDP)
(millions US$)
188,412 2009 World Bank
2011
1.01.04 GDP growth (Annual %) 4.6 2009 World Bank
2011
1.01.05C GDP per capita (US$ current
exchange rate)
2009 Worldbank
2011
1.01.06 Comments and References World Health Statistics (World Health Survey)
http://www.who.int/whosis/whostat/EN_WHS2011_Full.pdf
1.01.01-Population total (,000) Page 154
1.01.02-Population growth rate ( Annual %) Page 154
World Bank Data
1.01.03-Total Growth Domestic Product (GDP) (million US)
http://data.worldbank.org/country/egypt-arab-republic
1.01.04- GDP growth (annual%)http://search.worldbank.org/data
2,270
Pharmaceutical Sector Country Profile Questionnaire.
14
Supplementary questions (click here for help)
Year Source
1.01.07S Population < 15 years (% of total
population)
32 2009 WHS 2011
1.01.08S Population > 60 years (% of total
population)
7 2009 WHS 2011
1.01.09S Urban population (% of total
population)
43 2009 WHS2011
1.01.10S Fertility rate, total (Births per woman) 2.8 2009 WHS2011
1.01.11S Population living with less than
$1.25/day (international PPP) (%)
2.00 2005 World Bank
data2011
1.01.12S Population living below nationally
defined poverty line (%)
16.7 2000 World Bank
data2011
1.01.13S Income share held by lowest 20% of
the population (% of national income)
9 2005 World Bank
data2011
1.01.14S Adult literacy rate, 15+ years (% of
relevant population)
66 2008 WHS2011
1.01.15S Comments and References World Health Statistics (World Health Survey)
http://www.who.int/whosis/whostat/EN_WHS2011_Full.pdf
1.01.07S-Population < 15 years (% of total population) Page 154
1.01.08S- Population> 60 years (%of total population) Page 154
1.01.09S- Urban population (% of total population) Page 154
1.01.10S- Fertililty rate, total ( Births per woman) Page 155
World Bank Data
1.02 Mortality and Causes of Death
Core questions (click here for help)
Year Source
1.02.01 Life expectancy at birth for men 69 2009 WHS2011
Pharmaceutical Sector Country Profile Questionnaire.
15
(Years)
1.02.02 Life expectancy at birth for women
(Years)
73 2009 WHS2011
1.02.03 Infant mortality rate, between birth
and age 1 (/1,000 live births)
18 2009 WHS2011
1.02.04 Under 5 mortality rate
(/1,000 live births)
21 2009 WHS2011
1.02.05 Maternal mortality ratio ( /100,000 live
births)
82 2008 WHS 2011
1.02.06 Please provide a list of top
10 diseases causing
mortality
Yes 2010 Ministery of
Health
2011 (ref
attached)
1.02.06.01 Disease 1 Essential primary Hypertension
1.02.06.02 Disease 2 Intracerebral Haemorrhage
1.02.06.03 Disease 3 Fibrosis and cirrhosis of liver
1.02.06.04 Disease 4 Hepatic Failure
1.02.06.05 Disease 5 Atherosclerosis
1.02.06.06 Disease 6 Elevated Blood Glucose level
1.02.06.07 Disease 7 Arterial Embolisim and thrombosis
1.02.06.08 Disease 8 Acute myocardial infarction
1.02.06.09 Disease 9 Cerebral infarction
1.02.06.10 Disease 10 other
1.02.07 Please provide a list of top
10 diseases causing
morbidity
Yes
2010 Ministery of
Health
2011
1.02.07.01 Disease 1 Infectious Gastroenteritis
1.02.07.02 Disease 2 Spontaneous Labor
Pharmaceutical Sector Country Profile Questionnaire.
16
1.02.07.03 Disease 3 Caesarean section
1.02.07.04 Disease 4 Acute appendicitis
1.02.07.05 Disease 5 Iron deficiency anemia
1.02.07.06 Disease 6 Respiratory Distress Syndrome (RDS)
1.02.07.07 Disease 7 Broncho pneumonia
1.02.07.08 Disease 8 Acute tonsillitis
1.02.07.09 Disease 9 Forearm Fracture
1.02.07.10 Disease 10 Non specific renal colic
1.02.08 Comments and References World health statistics (World Health Survey)
http://www.who.int/whosis/whostat/EN_WHS2011_full.pdf
1.02.01-Life expectancy at birth for men ( years) Page 48
1.02.02-Life expectancy at birth for woman ( years) Page 48
1.02.03-Infant mortality rate between birth and age1 (/ 100,000 live
births) Page 49
1.02.04-Under 5 mortality rate (/ 1,000 birth rate) Page 49
1.02.05-Maternal Mortality Ratio (/ 100,000 live births) Page 62
1.02.05-Maternal Mortality Ratio value is 82 ( 51-130)
1.02.05-Maternal Mortality Ratio value was brought from WHS
(2011) not from WHS- interagency est
1.02.07.-Concerning Top 10 Morbidity diseases in Egypt questions:
Actually they are top 15 diseases and 45.8% of the in patients
discharged having those diseases in general and central hospitals.
The rest of the 5 top morbidity diseases are:
-Liver cirrhosis
-Heart Failure
-Essential Hypertension
Pharmaceutical Sector Country Profile Questionnaire.
17
-Bronchitis
-Assissted Labor
The refrences of such morbidity diseases:
Ministery of Health ( MOH)
1.02.06- concerning the top 10 diseases of mortality in Egypt:
Refrences From Ministery of Health
Supplementary questions (click here for help)
Year Source
1.02.09S Adult mortality rate for both sexes
between 15 and 60 years (/1,000
population)
174 2009 WHS2011
1.02.10S Neonatal mortality rate ( /1,000 live
births)
11 2009 WHS2011
1.02.11S Age-standardized mortality rate by
non-communicable diseases
(/100,000 population)
749 2008 WHS2011
1.02.12S Age-standardized mortality rate by
cardiovascular diseases (/100,000
population)
515 2009 WHS2011
1.02.13S Age-standardized mortality rate by
cancer ( /100,000 population)
81 2009 WHS2011
1.02.14S Mortality rate for HIV/AIDS (/100,000
population)
0.6 2009 WHS2011
1.02.15S Mortality rate for tuberculosis
(/100,000 population)
1.1 2009 WHS2011
1.02.16S Mortality rate for Malaria (/100,000
population)
0.2 2008 WHS2011
1.02.17S Comments and References World health statistics (World Health Survey)
http://www.who.int/whosis/whostat/EN_WHS2011_Full.pdf
1.02.09S-Adult mortality rate for both sexes between 15 and 60
years of age ( / 1000 population) Page 49
Pharmaceutical Sector Country Profile Questionnaire.
18
1.02.10S-Neonatal mortality rate (/ 1000 live births).Page 48
1.02.11S-Age standardized mortality rate by non communicable
diseases (/ 100,000 population).Page 63
1.02.14S- Mortality rate for HIV/AIDS among (/ 100,000 population)
Page 62
1.02.14S-* Mortality rate for HIV/AIDS value is 0.6 [0.5-0.9]
1.02.15S- Mortality rate for tuberculosis ( / 100,000 population)
among HIV negative.Page 62
1.02.15S-Mortality rate for tuberculosis value is 1.1 [0.7-1.5]
1.02.16S- Mortality rate for Malaria ( / 100,000 population). Page
62
1.02.16SThe value of mortality rate for malaria (/100,000
population) is 0.2 [0.1-0.2]
Pharmaceutical Sector Country Profile Questionnaire.
Section 2 Health Services
2.00 Respondent Information Section 2
2.00.01 Name of person responsible for filling
out this section of the instrument
Zahraa Hassan Abdelrahman
2.00.02 Phone number 202 0106500898
2.00.03 Email address [email protected]
2.00.04 Other respondents for filling out this
section
2.01 Health Expenditures
Core questions (click here for help)
Year Source
2.01.01.01 Total annual expenditure on health
(millions NCU)
61,400 2009 NHA 2011
2.01.01.02 Total annual expenditure on health
(millions US$ average exchange rate)
10,962 2009 average
Exchange
rate 2009:
5.601
2.01.02C Total health expenditure as % of
Gross Domestic Product
2.01.03.01C Total annual expenditure on health
per capita (NCU)
2.01.03.02C Total annual expenditure on health
per capita (US$ average exchange
rate)
2.01.04.01 General government annual
expenditure on health (millions NCU)
15,200 2009 NHA
2.01.04.02 General government annual
expenditure on health (millions
US$ average exchange rate)
2,576 2009 Exchange
rate
5/8/2011
2.01.05 Government annual expenditure on
health as percentage of total
government budget (% of total
4.3 2009 NHA data
5.8
740
132
Pharmaceutical Sector Country Profile Questionnaire.
20
government budget)
2.01.06C Government annual expenditure on
health as % of total expenditure on
health (% of total expenditure on
health)
2009 NHA
2.01.07.01C Annual per capita government
expenditure on health (NCU)
2.01.07.02C Annual per capita government
expenditure on health (US$ average
exchange rate)
2.01.08C Private health expenditure as % of
total health expenditure (% of total
expenditure on health)
2009 NHA 2011
2.01.09 Population covered by a public health
service or public health insurance or
social health insurance, or other
sickness funds of total
population)
51 2009 NHA 2011
2.01.10 Population covered by
private health insurance (%
of total population)
2.01.11.01 Total pharmaceutical expenditure
(millions NCU)
21,000 2009 NHA 2011
2.01.11.02 Total pharmaceutical expenditure
(millions US$ current exchange rate)
3,559.63 2099 Exchange
rate
5/8/2011
2.01.12.01C Total pharmaceutical expenditure per
capita (NCU)
2.01.12.02C Total pharmaceutical expenditure per
capita (US$ current exchange rate)
2.01.13C Pharmaceutical expenditure as a %
of GDP (% of GDP)
2.01.14C Pharmaceutical expenditure as a %
of Health Expenditure (% of total
health expenditure)
183.13
24.76
32.69
75.24
253
42.89
1.89
34.20
Pharmaceutical Sector Country Profile Questionnaire.
21
2.01.15.01 Total public expenditure on
pharmaceuticals (millions NCU)
2,567 2008 NHA data
2.01.15.02 Total public expenditure on
pharmaceuticals (millions
US$ current exchange rate)
435.11 2008 NHA data
2.01.16C Share of public expenditure on
pharmaceuticals as percentage of
total expenditure on pharmaceuticals
(%)
2011
2.01.17.01C Total public expenditure on
pharmaceuticals per capita (NCU)
2.01.17.02C Total public expenditure on
pharmaceuticals per capita
(US$ current exchange rate)
2.01.18.01 Total private expenditure on
pharmaceuticals (millions NCU)
8,445.71 2008 NHA data
2.01.18.02 Total private expenditure on
pharmaceuticals (millions
US$ current exchange rate)
1,431.45 2008 Exchange
rate
28/6/2011
2.01.19 Comments and References 2.01.01.01 NHA 2009
2.01.04.01 NHA data 2008, page 17, in this question government
expenditure is considered the same as public expenditure
2.01.09 the mentioned number is the percentage of total population
the absolute population number at year 2008 was 41 million (NHA
page 40) - this value is percent of population covered by health
insurance service only which is nearly the only type of this services
2.01.10 49% of population are unisnisured according to NHA 2009
2.01.11.01 NHA data page 17
2.01.15.01 Clear data is not available, it is calculated by subtracting
value of private pharmaceutical expenditure in NHA 2008 and total
pharmaceutical expenditure in NHA 2008.
2.01.18.01 NHA data 2008 page 33 in this question households are
considered the private expenditure as it represnts nearly all of the
private expenditure
23.31
31
5.6
Pharmaceutical Sector Country Profile Questionnaire.
22
Supplementary questions (click for help)
Year Source
2.01.20S Social security expenditure as % of
government expenditure on health (%
of government expenditure on health)
26.83 2008 NHA data
2.01.21S Market share of generic
pharmaceuticals [branded
and INN] by value (%)
2.01.22S Annual growth rate of total
pharmaceuticals market
value (%)
14.4 2010 IMS 2011
2.01.23S Annual growth rate of generic
pharmaceuticals market
value (%)
2.01.24S Private out-of-pocket expenditure
as % of private health expenditure
(% of private expenditure on
health)
95.14 2008 NHA data
2.01.25S Premiums for private prepaid health
plans as % of total private health
expenditure (% of private expenditure
on health)
0.22 2008 NHA data
2.01.26S Comments and References
2.02 Health Personnel and Infrastructure
Core questions (click for help)
Year Source
2.02.01 Total number of pharmacists
licensed/registered to
practice in your country
139,479 2011 Egyptian
pharmacy
syndicate
2.02.02C Pharmacists per 10,000 population
2.02.03 Total number of pharmacists
working in the public sector
15,457 2011 MOH
16.8
Pharmaceutical Sector Country Profile Questionnaire.
23
2.02.04 Total number of pharmaceutical
technicians and assistants
2.02.05 A strategic plan for pharmaceutical
human resource development is in
place in your country?
Yes No 2011 MOH-
CAPA
2.02.06 Total number of physicians 223,203 2011 Egyptian
medical
syndicate
2.02.07C Physicians per 10,000 pop
2.02.08 Total number of nursing and
midwifery personnel
280,561 2009 WHS 2011
2.02.09C Nurses and midwives per 10,000 pop
2.02.10 Total number of hospitals 1,969 2010 MOH 2011
2.02.11 Number of hospital beds per 10,000
pop
15.49 2010 MOH 2011
2.02.12 Total number of primary health care
units and centers
5034 2010 MOH 2011
2.02.13 Total number of licensed
pharmacies
59,798 2010 CAPA-
MOH 2011
2.02.14 Comments and References 2.02.01: Attached reference from database of egyptian pharmacy
syndicate (licensed pharmacist must be a member in the
syndicate)- The responsible person are Mr. Emad Faisal Mohamed
(lawyer) Tel:: 002 02 27958394
2.02.03: This number may be slightly lower than the actual number
because a small number work in miscellaneous public jobs and are
included in any total database.
2.02.04: There isn't any educational institution who teaches this
profession and certifies the graduates however thousands of
persons (with no certain reqiurements) do these tasks in
community pharmacies
2.02.05: The reference is central adminstration of pharmaceutical
affairs at ministry of health departement of QA and training the
responsible person is Dr.Heba mostafa telephone: 25354100-
attached document is the objectives of development however this
27
35.2
Pharmaceutical Sector Country Profile Questionnaire.
24
objectives not yet made into a plan
2.02.06: The attached refernce from egyptian medical syndicate-
the responsible person is Mr.Ahmed Morsy. Tel.: 002 02 27940738
2.02.08 There is no license or education for midwifery but for
nurses the data available in the syndicate- we contacted them
several times but no reply
2.02.11: Attached reference is from ministry of health- The written
no. is the total number of beds per 10.000 population while the
absolute total no. is 128573 beds
2.02.13: The mentioned number is only the community pharmacies
without the hospital pharmacies because there is no complete
database on hopital pharmcies
Supplementary questions (click here for help)
Year Source
2.02.15S Starting annual salary for a
newly registered pharmacist
in the public sector (NCU)
13,800 2011 Financial
Adminstrati
on- CAPA-
MOH
2.02.16S Total number of pharmacists who
graduated (first degree) in the
past 2 years in your country
2.02.17S Are there accreditation requirements
for pharmacy schools?
Yes No 2011 Supreme
Council of
Universities
2.02.18S Is the Pharmacy Curriculum regularly
reviewed?
Yes No 2011 Supreme
Council of
Universities
2.02.19S Comments and References 2.02.15S: This number is calculated in (NCU)- This value is the
mean for the salary the range is 700-1500 NCU
Pharmaceutical Sector Country Profile Questionnaire.
Section 3 Policy issues
3.00 Respondent Information Section 4
3.00.01 Name of person responsible for filling
out this section of the instrument
Andrew Botros Saleh Metry
3.00.02 Phone number 0020177386295
3.00.03 Email address [email protected]
3.00.04 Other respondents for filling out this
section
3.01 Policy Framework
Core questions (click here for help)
Year Source
3.01.01 National Health Policy exists. If yes,
please write year of the most
recent document in the "year"
field.
Yes No 2005 Health
System
Profile
Egypt
3.01.02 National Health Policy
Implementation plan exists. If yes,
please write the year of the
most recent document in the
"year"
Yes No 2006 Health
System
Profile
Egypt
3.01.03 Please provide comments on the
Health policy and its implementation
plan
3.01.04 National Medicines Policy official
document exists. If yes, please write
the year of the most recent document
in the "year" field.
Yes No 2005 WHO level
I
3.01.05 Group of policies addressing
pharmaceuticals exist.
Yes No 2009 Pharmacy
policies
and
procedures
, Health
Insurance
Information
Pharmaceutical Sector Country Profile Questionnaire.
26
3.01.06 National Medicines Policy covers the
following components:
Yes
3.01.06.01 Selection of Essential Medicines Yes
3.01.06.02 Medicines Financing Yes
3.01.06.03 Medicines Pricing Yes
3.01.06.04 Medicines Procurement Yes
3.01.06.05 Medicines Distribution Yes
3.01.06.06 Medicines Regulation Yes
3.01.06.07 Pharmacovigilance Yes
3.01.06.08 Rational Use of Medicines Yes
3.01.06.09 Human Resource Development Yes
3.01.06.10 Research Yes
3.01.06.11 Monitoring and Evaluation Yes
3.01.06.12 Traditional Medicine Yes
3.01.07 National medicines policy
implementation plan exists. If yes,
please write year of the most recent
document.
Yes No WHO level
I
3.01.08 Policy or group of policies on clinical
laboratories exist. If yes, please write
year of the most recent document in
the "year" field
Yes No
3.01.09 National clinical laboratory policy
implementation plan exists. If yes,
please write year of the most recent
document in the "year" field
Yes No
3.01.10 Access to essential
medicines/technologies as part of the
fulfillment of the right to health,
Yes No 2009 Pharmacy
policies
and
Pharmaceutical Sector Country Profile Questionnaire.
27
recognized in the constitution or
national legislation?
procedures
, Health
Insurance
Information
3.01.11 There are official written guidelines
on medicines donations.
Yes No 2007 WHO level
I
3.01.12 Is pharmaceutical policy
implementation being regularly
monitored/assessed?
Yes No 2009 Egyptian
Drug
Authority
3.01.12.01 Who is responsible for
pharmaceutical policy monitoring?
The Egyptian Drug Authority (EDA) consisting of Central
Administration of Pharmaceutical Affairs (CAPA), National
Organization for Drug Control and Research (NODCAR) & National
Organization For research & Control of Biologicals (NORCB)
3.01.13 Is there a national good governance
policy?
Yes No
3.01.13.01 Multisectoral Yes
3.01.13.02 For the pharmaceutical
sector
Yes
3.01.13.03 Which agencies are responsible?
3.01.14 A policy is in place to manage and
sanction conflict of interest issues in
pharmaceutical affairs.
Yes No 1978 Law 47 for
Civilian
personnel
system
state
3.01.15 There is a formal code of conduct for
public officials.
Yes No 1978 Law 47 for
Civilian
personnel
system
state
3.01.16 Is there a whistle-blowing mechanism
allowing individuals to raise a
concern about wrongdoing occurring
in the pharmaceutical sector of your
country (ombudsperson)?
Yes No
3.01.16.01 Please describe: In each Ministry in the government, there's an office for Citizen's
Services, where any normal citizen can report any wrongdoing
Pharmaceutical Sector Country Profile Questionnaire.
28
occurred with him in that ministry. Then this complaint is processed
for further investigation.
3.01.17 Comments and References 3.01.01: Health System Profile Egypt, Regional Health Sytem
Observatory, WHO, 2006. available at:
http://gis.emro.who.int/HealthSystemObservatory/PDF/Egypt/Full%
20Profile.pdf
3.01.05 Pharmacy policies and procedures, Health Insurance
Information (Arabic only), 2009.
http://www.mohp.gov.eg/DocLib6/Pharmacy%20policies%20_%20p
rocedures.pdf;
Regarding 3.01.06.03, see Section 6
Regarding Qu 3.01.08, this is an area of increased focus and is
currenmtly work in progress to finalize it's legistlation
3.01.12 Egyptian Drug Authority,
http://www.eda.mohp.gov.eg/About/EDAWelcome.aspx?Main=abo
ut&aboutid=1&SubAbout=55
Pharmaceutical Sector Country Profile Questionnaire.
Section 4 Medicines Trade and Production
4.00 Respondent Information Section 4
4.00.01 Name of person responsible for filling
out this section of the instrument
Andrew Botros Saleh Metry
4.00.02 Phone number 0020177386295
4.00.03 Email address [email protected]
4.00.04 Other respondents for filling out this
section
Raghda Shehab Eldin Abd Ellatif
4.01 Intellectual Property Laws and Medicines
Core questions (click here for help)
Year Source
4.01.01 Country is a member of the World
Trade Organization
Yes No 1995 WTO
4.01.02 Legal provisions provide for granting
of Patents on:
Yes
2007 WHO level
I
4.01.02.01 Pharmaceuticals Yes No
4.01.02.02 Laboratory supplies Yes No
4.01.02.03 Medical supplies Yes No
4.01.02.04 Medical equipment Yes No
4.01.03.01 Please provide name and address of
the institution responsible for
managing and enforcing intellectual
property rights
Egyptian Patent Office (ASRT)
Addess: 101 Kasr-Eni St.
Tel No.: 0020227921272
4.01.03.02 Please provide URL http://www.egypo.gov.eg/
4.01.04 National Legislation has been
modified to implement the TRIPS
Agreement
Yes No 2007 WHO level
I
4.01.05 Current laws contain (TRIPS) Yes No 2002 Law no. 82
Pharmaceutical Sector Country Profile Questionnaire.
30
flexibilities and safeguards
4.01.06 Country is eligible for the transitional
period to 2016
Yes No
4.01.07 Which of the following (TRIPS)
flexibilities and safeguards are
present in the national law?
Yes
2007 WHO level
I
4.01.07.01 Compulsory licensing provisions that
can be applied for reasons of public
health
Yes No
4.01.07.02 Bolar exception Yes No
4.01.08 Are parallel importing provisions
present in the national law?
Yes No 2007 WHO level
I
4.01.09 The country is engaged in initiatives
to strengthen capacity to manage and
apply intellectual property rights to
contribute to innovation and promote
public health
Yes No
4.01.10 Are there legal provisions for data
exclusivity for pharmaceuticals
Yes No
4.01.11 Legal provisions exist for patent
extension
Yes No
4.01.12 Legal provisions exist for linkage
between patent status and Marketing
Authorization
Yes No
4.01.13 Comments and References 4.01.05 Intellectual Property Law No. 82, 2002. Available at:
http://www.egypo.gov.eg/inner/english/PDFs/law2002e.pdf, 30-06-
2011.
Regarding 4.01.09, we have 3 projects with WIPO for innovation:
TISC, TTO & IPAcademy
4.02 Manufacturing
Core questions (click here for help)
Year Source
Pharmaceutical Sector Country Profile Questionnaire.
31
4.02.01 Number of licensed pharmaceutical
manufacturers in the country
119 2011 Pharmaceu
tical
Licensing
Administrati
on - CAPA
4.02.02 Country has manufacturing capacity
Yes
2011 Pharmaceu
tical
Licensing
Administrati
on - CAPA
4.02.02.01 R&D to discover new active
substances
Yes No Unknown
4.02.02.02 Production of pharmaceutical starting
materials (APIs)
Yes No Unknown
4.02.02.03 Production of formulations from
pharmaceutical starting material
Yes No Unknown
4.02.02.04 Repackaging of finished dosage
forms
Yes No Unknown
4.02.03 Percentage of market share by value
produced by domestic manufacturers
(%)
4.02.04 Comments and References There is a hardware attached document enlisting all the licensed
pharmaceutical manufacturers in Egypt with their coresponding
lines of production.
Supplementary questions (click here for help)
Year Source
4.02.05S Percentage of market share by
volume produced by
domestic manufacturers (%)
4.02.06S Number of multinational
pharmaceutical companies
manufacturing medicines locally
18 2011 Commercia
l Record
4.02.07S Number of manufacturers that are
Good Manufacturing Practice
Pharmaceutical Sector Country Profile Questionnaire.
32
(GMP) certified
4.02.08S Comments and References
Pharmaceutical Sector Country Profile Questionnaire.
33
Section 5 Medicines Regulation
5.00 Respondent Information Section 4
5.00.01 Name of person responsible for filling
out this section of the instrument
Gihan Hamdy
5.00.02 Phone number 20127366018
5.00.03 Email address [email protected]
5.00.04 Other respondents for filling out this
section
5.01 Regulatory Framework
Core questions (click here for help)
Year Source
5.01.01 Are there legal provisions
establishing the powers and
responsibilities of the Medicines
Regulatory Authority (MRA)?
Yes No 2007
WHO level
I
5.01.02 There is a Medicines Regulatory
Authority
Yes No 2007
WHO level
I
5.01.03 If yes, please provide name and
address of the Medicines regulatory
authority
Central Administration for pharmaceutical affairs (CAPA)
21 Abd Elaziz Alsood, Rawdat Elmanial, Cairo Egypt
5.01.04 The Medicines Regulatory Authority
is:
Yes 2011 EDA
website
5.01.04.01 Part of MoH Yes
5.01.04.02 Semi autonomous agency Yes
5.01.04.03 Other (please specify)
5.01.05 What are the functions of the
National Medicines Regulatory
Authority?
Yes 2011 EDA
website
Pharmaceutical Sector Country Profile Questionnaire.
34
5.01.05.01 Marketing authorization / registration Yes No
5.01.05.02 Inspection Yes No
5.01.05.03 Import control Yes No
5.01.05.04 Licensing Yes No
5.01.05.05 Market control Yes No
5.01.05.06 Quality control Yes No
5.01.05.07 Medicines advertising and promotion Yes No
5.01.05.08 Clinical trials control Yes No
5.01.05.09 Pharmacovigilance Yes No
5.01.05.10 Other: (please explain)
5.01.06 Number of the MRA permanent staff 820 2011 CAPA
5.01.06.01 Date of response 09-06-2011
5.01.07 The MRA has its own website Yes No 2009 WHO 2011
5.01.07.01 - If yes, please provide MRA Web
site address (URL)
http://www.eda.mohp.gov.eg/
5.01.08 The MRA receives external technical
assistance
Yes No 2009 EDA
website
decree 296
5.01.08.01 If yes, please describe: Technical comitties formed of external professors
5.01.09 The MRA is involved in
harmonization/ collaboration
initiatives
Yes No 2007 WHO level
I
5.01.09.01 - If yes, please specify
5.01.10 An assessment of the medicines
regulatory system has been
conducted in the last five years.
Yes No 2010 WHO 2011
5.01.11 Medicines Regulatory Authority gets
funds from regular budget of the
Yes No 2009 EDA
website
Pharmaceutical Sector Country Profile Questionnaire.
35
government. decree 26
5.01.12 Medicines Regulatory Authority is
funded from fees for services
provided.
Yes No 2009 EDA
website
decree 26
5.01.13 Medicines Regulatory Authority
receives funds/support from other
sources
Yes No
5.01.13.01 - If yes, please specify
5.01.14 Revenues derived from regulatory
activities are kept with the Regulatory
Authority
Yes No 2009 EDA
website
decree 26
5.01.15 The Regulatory Authority is using a
computerized information
management system to store and
retrieve information on registration,
inspections, etc.
Yes No 2011 EDA
website
5.01.16 Comments and References 5.01.11/12
http://www.eda.mohealth.gov.eg/Download/Docs/Decree_26_2009.
5.01.14 (comment: 50 % from revenues to Regularity Authority)
http://www.eda.mohealth.gov.eg/Download/Docs/Decree_26_2009.
5.02 Marketing Authorization (Registration)
Core questions (click here for help)
Year Source
5.02.01 Legal provisions require a Marketing
Authorization (registration) for all
pharmaceutical products on the
market
Yes No 2009 EDA
website
decree 296
Pharmaceutical Sector Country Profile Questionnaire.
36
5.02.02 Are there any mechanism for
exception/waiver of registration?
Yes No 2009 EDA
website
decree 296
5.02.03 Are there mechanisms for recognition
of registration done by other
countries
Yes No 2009 EDA
website
decree 296
5.02.03.01 If yes, please explain: under certain requirements : 1-For prescriptions only
2-Reports from physicians
3-Through Egyptian drug distribution company
5.02.04 Explicit and publicly available criteria
exist for assessing applications for
Marketing Authorization of
pharmaceutical products
Yes No 2009 EDA
website
decree 296
5.02.05 Information from the prequalification
programme managed by WHO is
used for product registration
Yes No 2009 EDA
website
decree 296
5.02.06 Number of pharmaceutical products
registered in your country
8,973 2011 EDA
website
5.02.07 Legal provisions require the MRA to
make the list of registered
pharmaceuticals with defined
periodicity publicly available
Yes No 2009 EDA
website
decree 296
5.02.07.01 If yes, how frequently
updated
every 10 years
5.02.07.02 If yes, please provide updated list or
URL *
http://www.eda.mohealth.gov.eg/Services/Drug_Hum.aspx?Main=S
ervices&Serviceid=2&Submain=serv7
5.02.08 Medicines registration always
includes the INN (International Non-
proprietary Names)
Yes No 2011 EDA
website
5.02.09 Legal provisions require the payment
of a fee for Medicines Marketing
Yes No 2009 EDA
website
Pharmaceutical Sector Country Profile Questionnaire.
37
Authorization (registration)
applications
decree 26
5.02.10 Comments and References 5.02.04
http://www.eda.mohealth.gov.eg/Services/Drug_Hum.aspx?Main=S
ervices&Serviceid=2&Submain=serv7
5.02.01/2/5/7
http://www.eda.mohealth.gov.eg/Download/Docs/MinisterDec296.p
df
5.02.06
8973 pharmaceutical products + 379 Biological products
5.02.08
http://www.eda.mohealth.gov.eg/Services/Drug_Hum.aspx?Main=S
ervices&Serviceid=2&Submain=serv7
Supplementary questions (click here for help)
Year Source
5.02.11S Legal provisions require Marketing
Authorization holders to provide
information about variations to the
existing Marketing Authorization
Yes No 2009 EDA
website
decree 296
5.02.12S Legal provisions require publication
of a Summary of Product
Characteristics (SPCs) of the
medicines registered
Yes No 2009 EDA
website
decree 296
5.02.13S Legal provisions require the
establishment of an expert committee
involved in the marketing
authorization process
Yes No 2009 EDA
website
decree 296
5.02.14S Certificate for Pharmaceutical
Products in accordance with the
WHO Certification scheme is required
as part of the Marketing Authorization
application
Yes No 2009 EDA
website
decree 296
5.02.15S Legal provisions require declaration
of potential conflict of interests for the
experts involved in the assessment
and decision-making for registration
Yes No 1978 decree 47
Pharmaceutical Sector Country Profile Questionnaire.
38
5.02.16S Legal provisions allow applicants to
appeal against MRAs decisions
Yes No 2009 EDA
website
decree 296
5.02.17S Registration fee - the amount per
application for pharmaceutical
product containing New Chemical
Entity (NCE) (US$)
1,675 2009 EDA
website
decree 26
5.02.18S Registration fee - the Amount per
application for a generic
pharmaceutical product
(US$)
1,675 2009 EDA
website
decree 26
5.02.19S Time limit for the assessment of a
Marketing Authorization application
(months)
12 2009 EDA
website
decree 296
5.02.20S Comments & References 5.02.14s CPP required for imported drugs only
5.02.17s, 5.02.18s date of exchange 28/6/2011
5.02.19s it depend on other factors
5.03 Regulatory Inspection
Core Questions(click here for help)
Year Source
5.03.01 Legal provisions exist allowing for
appointment of government
pharmaceutical inspectors
Yes No 1994 EDA
website
decree 281
5.03.02 Legal provisions exist permitting
inspectors to inspect premises where
pharmaceutical activities are
performed
Yes No 2007 WHO level
I
5.03.02.01 If yes, legal provisions exist requiring
inspections to be performed
Yes No
5.03.03 Inspection is a pre-requisite for 2009 EDA
Pharmaceutical Sector Country Profile Questionnaire.
39
licensing of: Yes website
decree 25
5.03.03.01 Public facilities Yes No
5.03.03.02 Private facilities Yes No
5.03.04 Inspection requirements are the
same for public and private
facilities
Yes No 2009 EDA
website
decree 25
5.03.05.01 Local manufactures are inspected for
GMP compliance
Yes No 2007 WHO level
I
5.03.05.02 Private wholesalers are inspected Yes No
5.03.05.03 Retail distributors are inspected Yes No
5.03.05.04 Public pharmacies and stores are
inspected
Yes No
5.03.05.05 Pharmacies and dispensing points of
health facilities are inspected
Yes No
5.03.05.06 Please provide details on frequency
of inspections for the different
categories of facilities
frequently and unexpected inspection
5.03.06 Comments and References 5.03.04 Inspection requirements are the same except:
1- The expired drugs in the public facilities are not
present however in private facilities they present in isolated
place until returned to suppliers.
2- Inspection on Inventory present in public facilities
only.
5.04 Import Control
Core Questions (click here for help)
Year Source
5.04.01 Legal provisions exist requiring
authorization to import medicines
Yes No 1994 EDA
website
Pharmaceutical Sector Country Profile Questionnaire.
40
decree 132
5.04.02 Legal provisions exist allowing the
sampling of imported products for
testing
Yes No 1994 EDA
website
decree 132
5.04.03 Legal provisions exist requiring
importation of medicines through
authorized ports of entry
Yes No 1994 EDA
website
decree 132
5.04.04 Legal provisions exist allowing
inspection of imported
pharmaceutical products at the
authorized ports of entry
Yes No
5.04.05 Comments and References
5.05 Licensing
Year Source
5.05.01 Legal provisions exist requiring
manufacturers to be licensed
Yes No 2007 WHO level
I
5.05.02 Legal provisions exist requiring both
domestic and international
manufacturers to comply with Good
manufacturing Practices (GMP)
Yes No 2007 EDA
website
decree 539
5.05.02.01 If no, please explain
5.05.03 GMP requirements are published by
the government.
Yes No 2007 EDA
website
decree 539
5.05.04 Legal provisions exist requiring
importers to be licensed
Yes No 2007 WHO level
I
5.05.05 Legal provisions exist requiring
wholesalers and distributors to be
licensed
Yes No 2009 EDA
website
decree 25
5.05.06 Legal provisions exist requiring
wholesalers and distributors to
Yes No 2009 EDA
Pharmaceutical Sector Country Profile Questionnaire.
41
comply with Good Distributing
Practices
When filling in this part, please also fill in the relevant questions in the procurement and distribution section (Section 7)
website
decree 25
5.05.07 National Good Distribution Practice
requirements are published by the
government
Yes No 2009 EDA
website
decree 25
5.05.08 Legal provisions exist requiring
pharmacists to be registered
Yes No 2011 EDA
website
5.05.09 Legal provisions exists requiring
private pharmacies to be licensed
Yes No 2011 EDA
website
5.05.10 Legal provision exist requiring public
pharmacies to be licensed
Yes No 2011 EDA
website
5.05.11 National Good Pharmacy Practice
Guidelines are published by the
government
Yes No 2011 EDA
website
5.05.12 Legal provisions require the
publication of a list of all licensed
pharmaceutical facilities
Yes No 2011 EDA
website
5.05.13 Comments and References 5.05.02
http://www.eda.mohealth.gov.eg/Download/Docs/Minister_Decree_
539_Both.pdf
5.05.05/06
http://www.eda.mohealth.gov.eg/Download/Docs/New_Minister_De
cree_for_Wholesalers.pdf
5.05.12
There is database in every Directorate
5.06 Market Control and Quality Control
Pharmaceutical Sector Country Profile Questionnaire.
42
Core Questions (click here for help)
Year Source
5.06.01 Legal Provisions for regulating the
pharmaceutical market exist
Yes No 2009 EDA
website
decree 296
5.06.02 Does a laboratory exist in the country
for Quality Control testing?
Yes No 2011 EDA
website
5.06.02.01 If yes, is the laboratory part of the
MRA?
Yes No
5.06.02.02 Does the regulatory authority contract
services elsewhere?
Yes No
5.06.02.03 If yes, please describe National Organization For research & Control of Biologicals
Ensure the Safety, quality and efficacy of all imported and
domestic Biologicals in Compliance with WHO requirements &
international organization for standardization
5.06.03 Is there any national laboratory
accepted for collaboration with WHO
prequalification Programme? Please
describe.
yes
National Oganization for Drug Control and Research (NODCAR)
5.06.04 Medicines are tested:
s
2009 EDA
website
decree 296
5.06.04.01 For quality monitoring in the public
sector (routine sampling in pharmacy
stores and health facilities)
Yes No
5.06.04.02 For quality monitoring in private
sector (routine sampling in retail
outlets)
Yes No
5.06.04.03 When there are complaints or
problem reports
Yes No
5.06.04.04 For product registration Yes No
5.06.04.05 For public procurement Yes No
Pharmaceutical Sector Country Profile Questionnaire.
43
prequalification
5.06.04.06 For public program products prior to
acceptance and/or distribution
Yes No
5.06.05 Samples are collected by
government inspectors for
undertaking post-marketing
surveillance testing
Yes No 2007 WHO level
I
5.06.06 How many Quality Control samples
were taken for testing in the last two
years?
48706 2010 NODCAR
report
5.06.07 Total number of samples tested in
the last two years that failed to meet
quality standards
277 2010 NODCAR
report
5.06.08 Results of quality testing in past two
years are publicly available
Yes No 2011 NODCAR
report
5.06.09 Comments and References 5.06.01
http://www.eda.mohealth.gov.eg/Download/Docs/MinisterDec296.p
df
5.07 Medicines Advertising and Promotion
Core Questions (click here for help)
Year Source
5.07.01 Legal provisions exist to control the
promotion and/or advertising of
prescription medicines
Yes No 2008 Decree 106
5.07.02 Who is responsible for regulating,
promotion and/or advertising of
medicines? Please describe:
Medicnes Regulatory Authority (Central Administration for
Pharmaceutical Affairs) responsible for reviewing scientific and
marketing materials
5.07.03 Legal provisions prohibit direct
advertising of prescription medicines
to the public
Yes No 2008 Decree
106
5.07.04 Legal provisions require a pre-
approval for medicines
Yes No 2007 WHO level
Pharmaceutical Sector Country Profile Questionnaire.
44
advertisements and promotional
materials
I
5.07.05 Guidelines/Regulations exist for
advertising and promotion of non-
prescription medicines
Yes No 2007 WHO level
I
5.07.06 A national code of conduct exists
concerning advertising and promotion
of medicines by marketing
authorization holders and is publicly
available
Yes No
5.07.06.01 If yes, the code of conduct applies to
domestic manufacturers only,
multinational manufacturers only, or
both
Yes No
Domestic only Yes
Multinational only Yes
Both Yes
5.07.06.02 If yes, adherence to the code is
voluntary
Yes No
5.07.06.03 If yes, the code contains a formal
process for complaints and sanctions
Yes No
5.07.06.04 If yes, list of complaints and
sanctions for the last two years is
publicly available
Yes No
5.07.07 Comments and References
5.08 Clinical trials
Core Questions (click here for help)
Year Source
5.08.01 Legal provisions exist requiring
authorization for conducting Clinical
Yes No
Pharmaceutical Sector Country Profile Questionnaire.
45
Trials by the MRA
5.08.02 Legal provisions exist requiring the
agreement by an ethics committee/
institutional review board of the
Clinical Trials to be performed
Yes No
5.08.03 Legal provisions exist requiring
registration of the clinical trials into
international/national/regional registry
Yes No
5.08.04 Comments and References Work in progress , and active steps are being taken for soon
implementation
Supplementary questions (click here for help)
Year Source
5.08.05S Legal provisions exist for GMP
compliance of investigational
products
Yes No
5.08.06S Legal provisions require sponsor,
investigator to comply with Good
Clinical Practices (GCP)
Yes No
5.08.07S National GCP regulations are
published by the Government.
Yes No
5.08.08S Legal provisions permit inspection of
facilities where clinical trials are
performed
Yes No
5.08.09S Comments and References
5.09 Controlled Medicines
Core Questions (click here for help)
Date Source
5.09.01 The country has adopted the
following conventions:
Yes
5.09.01.01 Single Convention on Narcotic Drugs,
1961
Yes No 1966 Internation
al Narcotics
Control
Board
Pharmaceutical Sector Country Profile Questionnaire.
46
5.09.01.02 The 1972 Protocol amending the
Single Convention on Narcotic Drugs,
1961
Yes No 1974 Internation
al Narcotics
Control
Board
5.09.01.03 Convention on Psychotropic
Substances 1971
Yes No 1972 Internation
al Narcotics
Control
Board
5.09.01.04 United Nations Convention against
the Illicit Traffic in Narcotic Drugs and
Psychotropic Substances, 1988
Yes No 1991 Internation
al Narcotics
Control
Board
5.09.02 Laws for the control of narcotic and
psychotropic substances, and
precursors exist
Yes No 2009 EDA
website
Decree 350
5.09.03 Annual consumption of Morphine
(mg/capita)
0.2195122 2011 Internation
al Narcotics
Control
Board
5.09.04 Comments and References 5.09.02
http://www.eda.mohealth.gov.eg/Download/Docs/Decree350.pdf
Supplementary questions (click here for help)
Year Source
5.09.05S The legal provisions and regulations
for the control of narcotic and
psychotropic substances, and
precursors have been reviewed by a
WHO International Expert or Partner
Organization to assess the balance
between the prevention of abuse and
access for medical need
Yes No Unknown
5.09.05.01S If yes, year of review
5.09.06S Annual consumption of Fentanyl
(mg/capita)
0.02439024 2011 Internation
al Narcotics
Control
Board
Pharmaceutical Sector Country Profile Questionnaire.
47
5.09.07S Annual consumption of Pethidine
(mg/capita)
1.09756098 2011 Internation
al Narcotics
Control
Board
5.09.08S Annual consumption of Oxycodone
(mg/capita)
0.0304878 2011 Internation
al Narcotics
Control
Board
5.09.09S Annual consumption of Hydrocodone
(mg/capita)
0.06097561 2011 Internation
al Narcotics
Control
Board
5.09.10S Annual consumption of Phenobarbital
(mg/capita)
73.1707317 2011 Internation
al Narcotics
Control
Board
5.09.11S Annual consumption of Methadone
(mg/capita)
0.01219512 2011 Internation
al Narcotics
Control
Board
5.09.12S Comments and References
5.10 Pharmacovigilance
Core Questions (click here for help)
Year Source
5.10.01 There are legal provision in the
Medicines Act that provides for
pharmacovigilance activities as part
of the MRA mandate
Yes No 1995 Decree 397
5.10.02 Legal provisions exist requiring the
Marketing Authorization holder to
continuously monitor the safety of
their products and report to the MRA
Yes No 2010 Decree 2
5.10.03 Legal provisions about monitoring
Adverse Drug Reactions (ADR) exist
in your country
Yes No 1995 Decree 397
Pharmaceutical Sector Country Profile Questionnaire.
48
5.10.04 A national pharmacovigilance centre
linked to the MRA exists in your
country
Yes No 2010 Decree 2
5.10.04.01 If a national pharmacovigilance
centre exists in your country, how
many staff does it employ full-
time
7
5.10.04.02 If a national pharmacovigilance
center exists in your country, an
analysis report has been published in
the last two years.
Yes No
5.10.04.03 If a national pharmacovigilance
center exists in your country, it
publishes an ADR bulletin
Yes No
5.10.05 An official standardized form for
reporting ADRs is used in your
country
Yes No 2011 Egyptian
Pharmaco
Vigilance
Center
(EPVC)
5.10.06 A national Adverse Drug Reactions
database exists in your country
Yes No 2011 EPVC
5.10.07 How many ADR reports are in
the database?
91 2011 EPVC
5.10.08 How many reports have been
submitted in the last two years?
91 2011 EPVC
5.10.09 Are ADR reports sent to the WHO
database in Uppsala?
Yes No
5.10.09.01 If yes, number of reports sent
in the last two years
5.10.10 Is there a national ADR or
pharmacovigilance advisory
committee able to provide technical
assistance on causality assessment,
Yes No 2010 Decree 2
Pharmaceutical Sector Country Profile Questionnaire.
49
risk assessment, risk management,
case investigation and, where
necessary, crisis management
including crisis communication?
5.10.11 Is there a clear communication
strategy for routine communication
and crises communication?
Yes No
5.10.12 In the absence of a national
pharmacovigilance system, ADRs are
monitored in at least one public
health program (for example TB, HIV,
AIDS)?
Yes No
5.10.13 Please describe how you intend to
enhance the Pharmacovigilance
system
Recruiting and training more staff
Finalize our regulatory pharmacovigilance guidelines
Implementation of pharmacovigilance training on larger scale for
pharmaceutical companies and healthcare proffesionals
Expanding the awareness campaign to all governates
Expand speciality of EPVC to include medication errors
5.10.14 Comments and References 5.10.03 but reporting for healthcare professionals is optional not
mandatory
5.10.04.01 6 pharmacists, 1 administrative assistant
5.10.04.02 The National center established in january 2010
5.10.05 http://www.epvc.gov.eg/images/Downloads/F_12.pdf
5.10.09. not yet
5.10.11 under development as part of EPVC guidelines
Supplementary questions (click here for help)
Year Source
5.10.15S Feedback is provided to reporters Yes No 2011 EPVC
5.10.16S The ADR database is computerized Yes No 2011 EPVC
Pharmaceutical Sector Country Profile Questionnaire.
50
5.10.17S Medication errors (MEs) are reported Yes No
5.10.18S How many MEs are there in the
ADRs database?
5.10.19S There is a risk management plan
presented as part of product dossier
submitted for Marketing
Authorization?
Yes No 2011 EPVC
5.10.20S
In the past two years, who has
reported ADRs?
Yes
2011
EPVC
5.10.20.01S Doctors Yes
5.10.20.02S Nurses Yes
5.10.20.03S Pharmacists Yes
5.10.20.04S Consumers Yes
5.10.20.05S Pharmaceutical Companies Yes
5.10.20.06S Others, please specify whom
5.10.21S Was there any regulatory decision
based on local pharmacovigilance
data in the last 2 years?
Yes No 2011 EPVC
5.10.22S Are there training courses in
pharmacovigilance?
Yes No 2011 EPVC
5.10.22.01S If yes, how many people have been
trained in the last two years?
2440 2011 EPVC
5.10.23S Comments and References 5.10.17S not yet but intended in future expansion
5.10.21S concerning poor quality products
Pharmaceutical Sector Country Profile Questionnaire.
Section 6 Medicines Financing
6.00 Respondent Information Section 5
6.00.01 Name of person responsible for filling
out this section of the instrument
raghda shehab elden abd elateef
6.00.02 Phone number 0020121468362
6.00.03 Email address [email protected]
6.00.04 Other respondents for this sections dr sawsan asaad general manager of pharmacy in HIO
dr maiada in pricing department
dr fatma in pricing department
DR ASHRAF KAMEL HEAD OF PRICING DEPARTMENT
dr hossam head of general pharmacy inspection
dr shimaa head of import approvals
dr moniur shokry MOH consultant
6.01 Medicines Coverage and Exemptions
Core Questions (click here for help)
Year Source
6.01.01 Do the followings receive medicines
free of charge:
Yes 2011 HIO
6.01.01.01 Patients who cannot afford them Yes No
6.01.01.02 Children under 5 Yes No
6.01.01.03 Pregnant women Yes No
6.01.01.04 Elderly persons Yes No
6.01.01.05 Please describe/explain your yes
answers for questions above
curative care free of charge treatment is offered by MOH curative
sector which covers 530 hospitals across egypt ,this hospitals
contain specialities more than that in HIO hospitals , for children
under 5 a request is offered where a card is offered to give
treatment free and it is expired after completing 6 years,elderly
over 60 years offer a request from pensione organization with birth
certificate
Pharmaceutical Sector Country Profile Questionnaire.
52
6.01.02 Is there a public health system or
social health insurance scheme or
public programme providing
medicines free of charge for :
Yes
2011 HIO
6.01.02.01 All medicines included in the EML Yes No
6.01.02.02 Any non-communicable diseases Yes No
6.01.02.03 Malaria medicines Yes No
6.01.02.04 Tuberculosis medicines Yes No
6.01.02.05 Sexually transmitted diseases
medicines
Yes No
6.01.02.06 HIV/AIDS medicines Yes No
6.01.02.07 Expanded Program on Immunization
(EPI) vaccines
Yes No
6.01.02.08 If others, please specify for antibilharzial and hepatitis C medicines
6.01.02.09 Please describe/explain your yes
answers for questions above
because this medicines related to endemic diseases in egypt
6.01.03 Does a national health insurance,
social insurance or other sickness
fund provide at least partial medicines
coverage?
Yes No 2001 ministerial
decree
number
1966
2011
6.01.03.01 Does it provide coverage for
medicines that are on the EML for
inpatients
Yes No
6.01.03.02 Does it provide coverage for
medicines that are on the EML for
outpatients
Yes No
6.01.03.03 Please describe the medicines benefit
of public/social insurance schemes
There are four broad classes of HIO beneficiaries:
1) Employees covered through Law 32 of the year 1975 (all
employees working in the government sector).
2) Employees covered through Law 79 of 1975 (some public and
Pharmaceutical Sector Country Profile Questionnaire.
53
private sector employees), and pensioners and widows.
3) Beneficiaries of the Student Health Insurance Program (SHIP)
by law number 99 for year1992 and covering more than 14 million
students, thus increasing the total beneficiary population from
4.895 million in 1992 to 20.67 million in 1995 (Egypt National
Health Accounts, 1995).
4) Newly-born children up to age five years, according to
ministerial decree number 380 for the year 1997an action that has
increased the beneficiary population by some 9 million, to include
approximately 55% of the Egyptian population.
6.01.04 Do private health insurance schemes
provide any medicines coverage?
Yes No 2006 attached
health
system
profile
egypt
2011
look title of
private
insurance
programms
,trends ,eli
gibility
6.01.04.01 If yes, is it required to provide
coverage for medicines that are on
the EML?
Yes No
6.01.05 Comments and References regarding question 6.01.02.01, 6.03.01 they offer coverage for
EML of HIO
question 6.01.03.03 also from health system profile egypt 2006
6.02 Patients Fees and Copayments
Core Questions (click here for help)
Year Source
6.02.01 In your health system, at the point of
delivery, are there any co-
payment/fee requirements for
consultations
Yes No 1975 law 79 for
pensioners
, law 32 for
governmen
t employee,
Pharmaceutical Sector Country Profile Questionnaire.
54
law 99 for
students,
law 380 for
neonates
6.02.02 In your health system, at the point of
delivery, are there any co-
payment/fee requirements for
medicines
Yes No 1975 law 79 for
pensioners
, law 32 for
governmen
t employee,
law 99 for
students,
law 380 for
neonates
6.02.03 In practice, (even though this may be
contrary to regulations) is revenue
from fees or sales of medicines
sometimes used to pay the salaries
or supplement the income of public
health personnel in the same facility?
Yes No
6.02.03.01 Please describe the patient fees and
copayments system
according to the laws mentioned above , for pensioners pay 1% of
their salaries for insurance for consultations and medicines in HIO
hospitals and receive consultations and medicines for free , for
government employee pay 0.5% of their salaries but pays about
1L.E for receiving medicines only , students pay 12L.E with School
fees
6.02.04 Comments and References for question 6.02.01 and 6.02.02
law 79 for year 1975 for pensioners , law 32 for year1975 for
government employee, law 99 for year 1992, law 380 for year 1997
6.03 Pricing Regulation for the Private Sector
Core Questions (click here for help)
Year Source
6.03.01 Are there legal or regulatory
provisions affecting pricing of
medicines
Yes No 2009 minsterial
decree
number
373 ,
314 , 38 ,
Pharmaceutical Sector Country Profile Questionnaire.
55
150,
, 313
2011
6.03.01.01 If yes, are the provisions aimed at
Manufacturers
Yes No
6.03.01.02 If yes, are the provisions aimed at
Wholesalers
Yes No
6.03.01.03 If yes, are the provisions aimed at
Retailers
Yes No
6.03.01.04 Please explain the positive answers
above: (explain scope of provisions
i.e generics vs. originator or subsets
of medicines, EML etc.)
These provisions applied to all types of medicines in the market
generics , originater, EML
6.03.02 Government runs an active national
medicines price monitoring system
for retail prices
Yes No 1980 according
to law 108
2011
attached
inspection
checklist on
pharmacies
6.03.03 Regulations exists mandating that
retail medicine price information
should be publicly accessible
Yes No 2011 eda.moheal
th.gov.eg/s
ervices/CA
PA
committee/
pricing
comittee
6.03.03.01 -if yes, please explain how the
information is made publically
available
eda.mohealth.gov.eg/services/CAPA committee/pricing comittee
6.03.04 Comments and References for question 6.03.01
minsterial decree number 373 for year 2009 , 314 year1992, 38
year 1993, 298 year2006,150 year1990 , 313 for year 1991
6.04 Prices, Availability and Affordability
Pharmaceutical Sector Country Profile Questionnaire.
56
Core Questions (click here for help)
Year Source
6.04.01-04 Please state if a medicines price
survey using the WHO/HAI
methodology has been conducted in
the past 5 years in your country.
If yes, please indicate the year of the
survey and use the results to fill in this
table
If no, but other surveys on medicines
prices and availability have been
conducted, please do not use them to
fill in this section, but rather use the
comment box to write some of the
results and attach the report to the
questionnaire
Yes No Unknown 2004 survey
report of
the prices
people
have to pay
for
medicines
in Egypt
Basket Of key medicines Public
procurement Public patient
Private
patient
Availability (one
or both of)
Mean (%)
Orig 6.04.01.01
100
6.04.01.03
100
LPG 6.04.01.02
100
6.04.01.04
100
Median (%)
Orig 6.04.02.01
6.04.02.03
LPG 6.04.02.02
6.04.02.04
Price Median Price Ratio
Orig 6.04.03.01
6.04.03.03
6.04.03.05
2.73
LPG 6.04.03.02
0.95
6.04.03.04
0.95
6.04.03.06
1.69
Affordability
Days’ wages of the
Number of days’
Orig 6.04.04.01
6.04.04.03
Pharmaceutical Sector Country Profile Questionnaire.
57
lowest paid govt worker
for standard treatment
with co-trimoxazole for
a child respiratory
infection
wages LPG 6.04.04.02
0.3
6.04.04.04
0.5
6.04.05 Comments and References for question 6.04.01.01 , 6.04.01.02, 6.04.01.03 , 6.01.01.04
One explanation
for high availability in the public sector is that Egypt has an
Essential Drug List which corresponds very well with the core list
used in the survey. Although a few essential medicines have been
added by use of the supplementary list, average availability
remains high. Nevertheless, it has to be remembered that our
estimate is based on a one point in time investigation
for question 6.04.03.01 and 6.04.03.03
As no innovator brand product was found in the governmental
sector, the comparison of innovator brands between the sectors
becomes impossible and we have compared only the prices of
generic equivalents
for question 6.04.04.02 and 6.04.04.04 this values are about
amoxicillin as ther isn't data about affordability of co-trimoxazole
in that survay
6.05 Price Components and Affordability
Core Questions (click here for help)
Year Source
6.05.01 Please state if a survey of medicines
price components has been
conducted in the past 5 years in your
country
Yes No Unknown
2004 survey
report of
the prices
people
have to
pay for
medicines
in egypt
6.05.02 Median cumulative percentage mark-
up between Manufacturer Selling
Price (MSP)/ Cost Insurance and
Freight (CIF) price and final medicine
price for a basket of key medicines in
Pharmaceutical Sector Country Profile Questionnaire.
58
the public sector (Median %
contribution)
6.05.03 Median cumulative percentage mark-
up between MSP/CIF price and final
medicine price for a basket of key
medicines in the private sector
(Median % contribution)
6.05.04 Comment and References data available isn't enough to fill this questions
Supplementary questions (click here for help)
6.05.05S Median percentage contribution of
MSP/CIF to final medicine price for a
basket of key medicines in the public
sector (Median % contribution)
6.05.06S Median percentage contribution of
MSP/CIF to final medicine price for a
basket of key medicines in the private
sector (Median % contribution)
6.05.07S Median manufacturer selling price
(CIF) as percent of final medicine
price for a basket of key medicines
(%)
6.05.08S Median wholesaler selling price as
percent of final medicine price for a
basket of key medicines (%)
6.05.09S Median pharmacist mark-up or
dispensing fee as percent of retail
price for a basket of key medicines
(%)
6.05.10S Median percentage contribution of the
wholesale mark-up to final medicine
price for a basket of key medicines (in
the public and private sectors) (%)
6.05.11S Median percentage contribution of the
retail mark-up to final medicine price
for a basket of key medicines (in the
public and private sectors) (%)
Pharmaceutical Sector Country Profile Questionnaire.
59
6.05.12S Comment and References
6.06 Duties and Taxes on Pharmaceuticals (Market)
Core Questions (click here for help)
Year Source
6.06.01 There are duties on imported active
pharmaceutical ingredients (APIs)
Yes No 1975 law 118 for
1975
ministerial
decree113
for year
1962
6.06.02 There are duties on imported finished
products
Yes No 1975 law 118 for
year 1975
ministerial
decree113
for year
1962
6.06.03 VAT (value-added tax) or any other
tax is levied on finished
pharmaceuticals products
Yes No 1991 law number
11 for year
1991
6.06.04 There are provisions for tax
exceptions or waivers for
pharmaceuticals and health products
Yes No 1991 ministerial
decree 314
for year
1992 and
law 11 of
1991
ministerial
decree
number
321 for
year 2010 ,
decree
709 for
year 1978
for acdema
companies
Pharmaceutical Sector Country Profile Questionnaire.
60
6.06.05 Please specify categories of
pharmaceuticals on which the taxes
are applied and describe the
exemptions and waivers that exist
taxes are applied to all pharmaceuticals except that stated in the
attached law 11 and ministerial decree 314 regarding medicines
of chronic diseases and products of acdema companies (which is
also duties free) , also all active ingredients tax free but first their
companies must apply request to CAPA to release ministerial
decree including a list of this materials Exempted like the decree
attached(321)
6.06.06 Comments and References
Supplementary questions (click here for help)
Year Source
6.06.07S Duty on imported active
pharmaceutical ingredients, APIs (%)
6.06.08S Duty on imported finished products
(%)
0.05 1975 law 118for
year 1975
look also
the
attached
cost sheet
6.06.09S VAT on pharmaceutical products (%) 0.05 1991 law number
11 for year
1991
look also
the
attached
cost sheet
6.06.10S Comments and References
Pharmaceutical Sector Country Profile Questionnaire.
Section 7 Pharmaceutical procurement and distribution
7.00 Respondent Information Section 6
7.00.01 Name of person responsible for
filling out this section of the
instrument
raghda shehab eldeen abd elateef
7.00.02 Phone number 0020121468362
7.00.03 Email address [email protected]
7.00.04 Other respondents for filling out this
section
dr rasha abo shady the head of procrutment department
dr hossam head of general pharmacy inspection
dr maha edres head of factories inspection
dr salwa zhran head of licening general pharmacy organization
7.01 Public Sector Procurement
Core Questions (click here for help)
Date Source
7.01.01 Public sector procurement is:
Yes 2011 look the
headline of
tender
condition
booklet
7.01.01.01 Decentralized
Yes
7.01.01.02 Centralized and decentralized
Yes
7.01.01.03 Please describe look flow chart attached illustrating the public procrutment process
7.01.02 If public sector procurement is
wholly or partially centralized, it is
under the responsibility of a
procurement agency which is:
Yes
2011 dr rasha
abo shady
the head of
procrutmen
department
Pharmaceutical Sector Country Profile Questionnaire.
62
7.01.02.01 Part of MoH Yes No
7.01.02.02 Semi-Autonomous Yes No
7.01.02.03 Autonomous Yes No
7.01.02.04 A government procurement agency
which procures all public goods
Yes No
7.01.03 Public sector requests for tender
documents are publicly available
Yes No 2010 elgomhoria
national
journal
7.01.04 Public sector tender awards are
publicly available
Yes No 2011 eda.moheal
th.gov.eg/A
nnounceme
nt
7.01.05 Procurement is based on
prequalification of suppliers
Yes No 2007 prequalifica
tion criteria
by dr rasha
aboshady
2011
7.01.05.01 If yes, please describe how it works A team from procrutment department make inspection visit in 2007 to
different drug suppliers according to this prequalification criteria then
fed the data in a database in IT of ministery of health , any suppliers
must fill the requiered criteria in this database before application to a
procrutment process and any changes or addition regarding their
data fed it in this database
7.01.06 Comments and References for question 7.01.01public procurement process is centeralized for
hospitals , health units and Medical Convoys of ministery of health
and decenteralized because national procrutment agency hasn't the
responsibility of procrutment process of univeristy hospitals which
follow ministery of heigher education
Supplementary questions (click here for help)
Year Source
7.01.07S Is there a written public sector
procurement policy?. If yes, please
write the year of approval in the
"year" field
Yes No 1998 The law of
tenders
and
auctions 89
for
Pharmaceutical Sector Country Profile Questionnaire.
63
year1998
2011
7.01.08S Are there legal provisions giving
priority in public procurement to
goods produced by local
manufacturers?
Yes No 1998 The law of
tenders
and
auctions 89
for
year1998
2011
7.01.09S The key functions of the
procurement unit and those of the
tender committee are clearly
separated
Yes No 1998 The law of
tenders
and
auctions 89
for
year1998
2011
7.01.10S A process exists to ensure the
quality of products procured
Yes No 2011 tender
condition
booklet
and
attached
copy of
record of
inspection
of pulled
sampels
7.01.10.01S If yes, the quality assurance
process includes pre-qualification
of products and suppliers
Yes No
7.01.10.02S If yes, explicit criteria and
procedures exist for pre-
qualification of suppliers
Yes No
7.01.10.03S If yes, a list of pre-qualified
suppliers and products is publicly
available
Yes No
7.01.11S List of samples tested during the
procurement process and results of
Yes No 2010 attached
copy of
Pharmaceutical Sector Country Profile Questionnaire.
64
quality testing are available record of
inspection
of pulled
sampels
7.01.12S Which of the following tender
methods are used in public sector
procurement:
Yes
2011 dr rasha
abo shady
the head of
procrutmen
department
7.01.12.01S National competitive tenders Yes No
7.01.12.02S International competitive tenders Yes No
7.01.12.03S Direct purchasing Yes No
7.01.13S Comments and References 7.01.11s pulled sampels of procured drugs by inspection department
is known by suppliers
7.02 Public Sector Distribution
Core Questions (click here for help)
Year Source
7.02.01 The government supply system
department has a Central Medical
Store at National Level
Yes No
7.02.02 Number of public warehouses in
the secondary tier of public
distribution
(State/Regional/Provincial)
194 2011 attached
statistical
record
january
7.02.03 There are national guidelines on
Good Distribution Practices (GDP)
Yes No 2009 national
GDP for
pharmaceu
tical
products
2011
7.02.04 There is a licensing authority that Yes No 2009 Ministerial
Decree
Pharmaceutical Sector Country Profile Questionnaire.
65
issues GDP licenses number
380 and 25
2011
7.02.04.01 If a licensing authority exists, does
it accredit public distribution
facilities?
Yes No
7.02.05 List of GDP certified warehouses in
the public sector exists
Yes No
7.02.06 List of GDP certified distributors in
the public sector exists
Yes No
7.02.07 Comments and References for question 7.02.04.01 all the legal provisions regarding accrediting
and licinening the distribution facilities are only applicable to the
private sector and haven't direct authority on public ones , only send
recommendations to them to take this minsterial decrees 380 and 25
into considerations even upon inspection there is acheck list attached
for inspection according to GSP only
for question 7.02.02 that is the only number reported because no
reportes are received from Red Sea Governorate,el oksor
governerate,bany swef governerate andSouth Sinai
Supplementary questions (click here for help)
Year Source
7.02.08S Which of the following processes is
in place at the Central Medical
Store:
Yes
7.02.08.01S Forecasting of order quantities Yes No
7.02.08.02S Requisition/Stock orders Yes No
7.02.08.03S Preparation of picking/packing slips Yes No
7.02.08.04S Reports of stock on hand Yes No
7.02.08.05S Reports of outstanding order lines Yes No
7.02.08.06S Expiry dates management Yes No
7.02.08.07S Batch tracking Yes No
Pharmaceutical Sector Country Profile Questionnaire.
66
7.02.08.08S Reports of products out of stock Yes No
7.02.09S Percentage % availability of key
medicines at the Central Medical
Store
7.02.10S Average stock-out duration for a
basket of medicines at the Central
Medical Store, in days
7.02.11S Routine Procedure exists to track
the expiry dates of medicines at the
Central Medical Store
Yes No
7.02.12S The Public Central Medical Store is
GDP certified by a licensing
authority
Yes No
7.02.13S The Public Central Medical Store is
ISO certified
Yes No
7.02.14S The second tier public warehouses
are GDP certified by a licensing
authority
Yes No
7.02.15S The second tier public warehouses
are ISO certified
Yes No
7.02.16S Comments and References
7.03 Private Sector Distribution
Core Questions (click here for help)
Year Source
7.03.01 Legal provisions exist for licensing
wholesalers in the private sector
Yes No 2009 ministerial
decree
number
380 for
year 2009
and
pharmacy
law 127 for
year 1955
code 40-
Pharmaceutical Sector Country Profile Questionnaire.
67
45
2011
7.03.02 Legal provisions exist for licensing
distributors in the private sector
Yes No 2009 ministerial
decree
number
380 for
year 2009
and
pharmacy
law 127 for
year 1955
code 40-45
2011
7.03.03 List of GDP certified wholesalers in
the private sector exists
Yes No 2011 national
distributers
list
7.03.04 List of GDP certified distributors in
the private sector exists
Yes No 2011 national
distributers
list
7.03.05 Comments and References
Pharmaceutical Sector Country Profile Questionnaire.
Section 8 Selection and rational use
8.00 Respondent Information Section 7
8.00.01 Name of person responsible for
filling out this section of the
instrument
Ghada Mohamed Ahmed
8.00.02 Phone number 202 0148522130
8.00.03 Email address [email protected]
8.00.04 Other respondents for filling out this
section
dr/ Rasha Aboushady
dr/ Hadir Mamdouh
dr/ Osama Ramadan
dr/ Nira Niazi
8.01 National Structures
Core Questions (click here for help)
Year Source
8.01.01 National essential medicines list
(EML) exists. If yes, please write
year of last update of EML in the
"year" field
Yes No 2006 WHO level
I
8.01.01.01 If yes, number of medicines on the
EML (no. of INN)
500
8.01.01.02 If yes, there is a written process for
selecting medicines on the EML
Yes No
8.01.01.03 If yes, the EML is publicly available Yes No
8.01.01.04 If yes, is there any mechanism in
place to align the EML with the
Standard Treatment Guidelines
(STG)
Yes No
8.01.02 National Standard Treatment
Guidelines (STGs) for most
common illnesses are
produced/endorsed by the MoH. If
yes, please insert year of last
Yes No 2010 MOH
2011
Pharmaceutical Sector Country Profile Questionnaire.
69
update of STGs in the "year" field
8.01.03 STGs specific to Primary care
exist. Please use the "year" field to
write the year of last update of
primary care guidelines
Yes No 2008 WHO level
I
8.01.04 STGs specific to Secondary care
(hospitals) exists. Please use the
"year" field to write the year of last
update of secondary care STGs.
Yes No 2006 WHO level
I
8.01.05 STGs specific to Paediatric
conditions exist. Please use the
"year" field to write the year of last
update of paediatric condition
STGs
Yes No 2010 MOH-Egypt
2011
8.01.06 % of public health facilities with
copy of EML (mean)- Survey data
41.2 2008 WHO
essential
drugs &
medicines
policy
8.01.07 % of public health facilities with
copy of STGs (mean)- Survey data
26.5 2008 WHO
essential
drugs &
medicines
policy
8.01.08 A public or independently funded
national medicines information
centre provides information on
medicines to prescribers,
dispensers and consumers
Yes No 2007 WHO level
I
8.01.09 Public education campaigns on
rational medicine use topics have
been conducted in the previous two
years
Yes No unavailable
8.01.10 A survey on rational medicine use
has been conducted in the previous
Yes No 2010 Central
Administer
ation of
Pharmaceutical Sector Country Profile Questionnaire.
70
two years Phamaceut
ical Affairs
(CAPA)-
EPVC-
MOH
2011
8.01.11 A national programme or
committee (involving government,
civil society, and professional
bodies) exists to monitor and
promote rational use of medicines
Yes No 2007 WHO level
I
8.01.12 A written National strategy exists to
contain antimicrobial resistance. If
yes, please write year of last
update of the strategy in the "year"
field
Yes No 2007 WHO level
I
8.01.13 Comments and References 8.01.01.02 , 8.01.01.03 , 8.01.01.04: The reference is Central
Administeration of Pharmaceutical Affairs (CAPA) - procurement
department the responsible person is dr. Rasha Aboshady
8.01.01.04: There is a mechanism to align the EML with the ( STG)
especially in oncology medicines.
8.01.11 Yes there is committee on facilities level to monitor drugs
utilization , following of clinical guidelines begining in 2002 and still
until now.
Supplementary questions (click here for help)
Year Source
8.01.14S The Essential Medicines List (EML)
includes formulations specific for
children
Yes No 2011 CAPA-
MOH
8.01.15S There are explicitly documented
criteria for the selection of
medicines in the EML
Yes No 2011 CAPA-
MOH
8.01.16S There is a formal committee or
other equivalent structure for the
selection of products on the
National EML
Yes No 2007 WHO level
I
Pharmaceutical Sector Country Profile Questionnaire.
71
8.01.16.01S If yes, conflict of interest
declarations are required from
members of national EML
committee
Yes No
8.01.17S National medicines formulary exists Yes No 2007 WHO level
I
8.01.18S Is there a funded national inter-
sectoral task force to coordinate
the promotion of appropriate use of
antimicrobials and prevention of
spread of infection?
Yes No 2008 MOH-
USAID-
Egypt
8.01.19S A national reference laboratory/or
any other institution has
responsibility for coordinating
epidemiological surveillance of
antimicrobial resistance
Yes No 2007 WHO level
I
8.01.20S Comments and References 8.01.14S , 8.01.15S , 8.01.16S , 8.01.16.01S: The reference is
Central Administeration of Pharmaceutical Affairs (CAPA) -
procurement department the responsible person is dr. Rasha
Aboshady
8.01.16S : Attached Reference from procurement departement at
CAPA - MOH
8.01.16.01s : Attached Reference from CAPA - MOH
8.01.18S URL:
http://www.mohp.gov.eg/programs/InfectFight/DocLib/part33.pdf
comment: usaid helps with the Egyptian government to improving the
country's infectious diseases surveillance system through the
Infection Control Program (ICP)
8.02 Prescribing
Core Questions (click here for help)
Year Source
8.02.01 Legal provisions exist to govern the Yes No 2011 Egyptian
Pharmaceutical Sector Country Profile Questionnaire.
72
licensing and prescribing practices
of prescriber
Medical
Syndicate
8.02.02 Legal provisions exist to restrict
dispensing by prescribers
Yes No 2011 Egyptian
Medical
Syndicate
8.02.03 Do prescribers in the private sector
dispense medicines?
Yes No 2007 WHO level
I
2011
8.02.04 Regulations require hospitals to
organize/develop Drug and
Therapeutics Committees (DTCs)
Yes No 2007 WHO level
I
2011
8.02.05 Do more than half of referral
hospitals have a DTC?
Yes No Unknown 2007 WHO level
I
2011
8.02.06 Do more than half of general
hospitals have a DTC?
Yes No Unknown 2007 WHO level
I
2011
8.02.07 Do more than half of
regions/provinces have a DTC?
Yes No Unknown 2007 WHO level
I
2011
8.02.08 The core medical training
curriculum includes components
on:
Yes
8.02.08.01 Concept of EML Yes No
8.02.08.02 Use of STGs Yes No
8.02.08.03 Pharmacovigilance Yes No
8.02.08.04 Problem based pharmacotherapy Yes No
8.02.09 Mandatory continuing education
that includes pharmaceutical issues
is required for doctors (see
physician)
Yes No 2007 WHO level
I
2011
Pharmaceutical Sector Country Profile Questionnaire.
73
8.02.10 Mandatory continuing education
that includes pharmaceutical issues
is required for nurses
Yes No nursing
syndicate
8.02.11 Mandatory continuing education
that includes pharmaceutical issues
is required for paramedical staff
Yes No 2007 WHO level
I
2011
8.02.12 Prescribing by INN name is
obligatory in:
Yes
2007 WHO level
I
8.02.12.01 Public sector Yes No
8.02.12.02 Private sector Yes No
8.02.13 Average number of medicines
prescribed per patient contact in
public health facilities (mean)
2.3 2008 MOH -
WHO
8.02.14 % of medicines prescribed in
outpatient public health care
facilities that are in the national
EML (mean)
88.47 2008 MOH -
WHO 2011
8.02.15 % of medicines in outpatient public
health care facilities that are
prescribed by INN name (mean)
37.5 2008 MOH -
WHO 2011
8.02.16 % of patients in outpatient public
health care facilities receiving
antibiotics (mean)
49.8 2008 MOH -
WHO
8.02.17 % of patients in outpatient public
health care facilities receiving
injections (mean)
13.2 2008 MOH -
WHO 2011
8.02.18 % of prescribed drugs dispensed to
patients (mean)
91.2 2008 MOH -
WHO 2011
8.02.19 % of medicines adequately labeled
in public health facilities (mean)
45.2 2008 MOH -
WHO 2011
8.02.20 Comments and References References: World Health Organization - Department of Essential
Drugs and Medicines Policy - Ministry of Health -( Egyptian National
Pharmaceutical Sector Country Profile Questionnaire.
74
Drug Policy Survey ) - Softcopy attached
Supplementary questions (click here for help)
Year Source
8.02.21S A professional association code of
conduct exists governing
professional behaviour of doctors
Yes No 2011 Egyptian
Medical
Syndicate
8.02.22S A professional association code of
conduct exists governing
professional behaviour of nurses
Yes No
8.02.23S Diarrhoea in children treated with
Oral Rehydration Solution (ORS)
(%)
85.1 2008 MOH -
WHO
2011
8.02.24S Comments and References 8.02.23S : data according to ( Egyptian National Drug Policy
Survey )- softcopy attached.
8.03 Dispensing
Core Questions (click here for help)
Year Source
8.03.01 Legal provisions exist to govern
dispensing practices of
pharmaceutical personnel
Yes No 2011 CAPA -
MOH
8.03.02 The basic pharmacist training
curriculum includes components
on:
Yes
8.03.02.01 Concept of EML Yes No
8.03.02.02 Use of STGs Yes No
8.03.02.03 Drug Information Yes No
8.03.02.04 Clinical pharmacology Yes No
8.03.02.05 Medicines supply management Yes No
Pharmaceutical Sector Country Profile Questionnaire.
75
8.03.03 Mandatory continuing education
that includes rational use of
medicines is required for
pharmacists
Yes No 2007 WHO level
I
8.03.04 Generic substitution at the point of
dispensing in public sector facilities
is allowed
Yes No 2007 WHO level
I
2011
8.03.05 Generic substitution at the point of
dispensing in private sector
facilities is allowed
Yes No 2007 WHO level
I
2011
8.03.06 In practice, (even though this may
be contrary to regulations) are
antibiotics sometimes sold over-
the-counter without any
prescription?
Yes No Unknown 2007 WHO level
I
2011
8.03.07 In practice, (even though this may
be contrary to regulations) are
injections sometimes sold over-the-
counter without any prescription?
Yes No Unknown 2007 WHO level
I
2011
8.03.08 Comments and References
Supplementary questions (click here for help)
Year Source
8.03.09S A professional association code of
conduct exists governing
professional behaviour of
pharmacists
Yes No 2011 Egyptian
Pharmacist
Syndicate
2011
8.03.10S In practice, (even though this may
be contrary to regulations) do the
following groups of staff sometimes
prescribe prescription-only
medicines at the primary care level
in the public sector?
Yes
2007 WHO level
I
8.03.10.01S Nurses Yes No Unknown
Pharmaceutical Sector Country Profile Questionnaire.
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8.03.10.02S Pharmacists Yes No Unknown
8.03.10.03S Paramedics Yes No Unknown
8.03.10.04S Personnel with less than
one month training
Yes No Unknown
8.03.11S Comments and References 8.03.09S Egyptian Pharmacist Syndicate
URL: egypharmsynd.org/files/h6.jpg - hardcopy attached.
Pharmaceutical Sector Country Profile Questionnaire.
Section 9 Household data/access
9.00 Respondent Information section 8
9.00.01 Name of person responsible for
filling out this section of the
instrument
9.00.02 Phone number
9.00.03 Email address
9.00.04 Other respondents for filling out this
section
9.01 Data from Household Surveys
Core Questions (click here for help)
Year Source
9.01.01 What household surveys have
been undertaken in the past 5
years to assess access to
medicines?
9.01.02 Adults with acute condition in two-
week recall period who took all
medicines prescribed by an
authorized prescriber (%)
9.01.03 Adults with acute conditions not
taking all medicines because they
cannot afford them (%)
9.01.04 Adults (from poor households) with
an acute health condition in two-
week recall period who took all
medicines prescribed by an
authorized prescriber (%)
9.01.05 Adults (from poor households) with
an acute condition in two-week
recall period who did not take all
medicines because they cannot
afford them (%)
Pharmaceutical Sector Country Profile Questionnaire.
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9.01.06 Adults with chronic conditions
taking all medicines prescribed by
an authorized prescriber (%)
9.01.07 Adults (from poor households) with
chronic conditions not taking all
medicines because they cannot
afford them (%)
9.01.08 Adults (from poor households) with
chronic conditions who usually take
all medicines prescribed by an
authorized prescriber (%)
9.01.09 Children (from poor households)
with an acute condition in two-week
recall period who took all medicines
prescribed by an authorized
prescriber (%)
9.01.10 Percentage of people who obtained
the medicines prescribed in the 15
days before the interview (%)
9.01.11 People who obtained prescribed
medicines for free in the 15 days
before the interview (%)
9.01.12 Comments and References
Supplementary questions (click here for help)
Year Source
9.01.13S Adults with acute conditions not
taking all medicines because the
medicines were not available (%)
9.01.14S Adults with chronic conditions not
taking all medicines because they
cannot afford them (%)
9.01.15S Adults with chronic conditions not
taking all medicines because the
medicines were not available (%)
9.01.16S Children with acute conditions
taking all medicines prescribed by
Pharmaceutical Sector Country Profile Questionnaire.
79
an authorized prescriber (%)
9.01.17S Children with acute conditions not
taking all medicines because they
cannot afford them (%)
9.01.18S Children with acute conditions not
taking all medicines because the
medicines were not available (%)
9.01.19S Children (from poor households)
with acute conditions not taking all
medicines because they cannot
afford them (%)
9.01.20S Comments and References
Pharmaceutical Sector Country Profile Questionnaire.
Key Documents to be attached
Document Exact title Author Publisher Year File name National Medicines Policy (NMP)
NMP implementation plan
National Medicines Act
National pharmaceutical human resources report or strategic plan
Latest report on the national pharmaceutical market (any source)
National Pharmacovigilance Centre report (including Adverse Drug Reaction, ADR, analysis report in the last two years)
National pharmaceutical legislation for regulation
Annual report of quality control laboratories
Annual report of national regulatory authority
Legal provisions on medicines price regulations
Medicines procurement policy
National Essential Medicines List (EML)
National Standard Treatment Guidelines (STGs)
National Strategy for anti-microbial resistance
Any other medicines